FLASCO / Drugs

NEW FDA approval- Stemline Therapeutics

Amanda Bridges
December 28, 2018
Drugs
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Stemline Therapeutics recently announced that the Food and Drug Administration (FDA) has approved ELZONRISTM (tagraxofusp-erzs; SL-401) for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN): https://ir.stemline.com/news-releases/news-release-details/fda-approves-elzonristm-tagraxofusp-first-treatment-blastic Full prescribing information can be found here:http://elzonris.com/hcp/resources/ELZONRIS_US_Full_Prescribing_Information.pdf ELZONRISTM will not be available for shipment until late January. We are currently in the process of finalizing a compliment of clinical and patient focused resources. …

FDA approves pembrolizumab for Merkel cell carcinoma

Amanda Bridges
December 20, 2018
Drugs
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On December 19, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Approval was based on Cancer Immunotherapy Trials Network protocol 9 (CITN-09), also known as KEYNOTE-017 (NCT02267603), a multicenter, non-randomized, open-label trial…

Reimbursement Update Permanent J code for Imfinzi

Amanda Bridges
December 14, 2018
Drugs
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IMFINZI is indicated for the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The NEW Permanent J-Code is J91731 and goes into effect January 1, 2019.

ASH 2018 News From Genentech

Amanda Bridges
December 14, 2018
Drugs
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This year at the American Society of Hematology (ASH) Annual Meeting, Genentech presented data for ten medicines in more than 70 abstracts, including 25 oral presentations [press release]. Highlighted data included new data from three Venclexta® (venetoclax) combination studies demonstrating deep responses in chronic lymphocytic leukemia and acute myeloid leukemia, two of the most common types…

Entrinsic Health Solutions and Markey Cancer Center Launch Phase II Study for Neuroendocrine Tumor Patients with Quality of Life-Limiting Diarrhea

Amanda Bridges
December 13, 2018
Drugs
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NORWOOD, Mass., Dec. 12, 2018 /PRNewswire/ — Entrinsic Health Solutions in partnership with the University of Kentucky (UK) Markey Cancer Center today announced initiation of active accrual and first consented patient in its Phase II study evaluating enterade® – a glucose-free, medical food – in neuroendocrine tumor and carcinoid syndrome patients. Findings from this study may show that enterade can…

Permanent J-codes for Genentech Hematology Products

Amanda Bridges
December 10, 2018
Drugs
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The Centers for Medicare & Medicaid Services (CMS) has made a change to the RITUXAN® (rituximab) J-code and has assigned a permanent J-code for RITUXAN HYCELA® (rituximab/hyaluronidase human subcutaneous injection). Effective January 1, 2019 J-code J9312 will replace J9310 for RITUXAN and the billable units will change from 100 mg to 10 mg. Additionally, the…

C-code for ONPATTRO™ (patisiran) lipid complex injection

Amanda Bridges
December 5, 2018
Drugs
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We are sending this communication on behalf of Alnylam Pharmaceuticals, Inc., to announce the assignment of a product‐specific temporary C-code for ONPATTRO™ (patisiran) lipid complex injection, for intravenous use. The Centers for Medicare & Medicaid Services (CMS) released the 2019 Alpha-Numeric HCPCS File, which included the designation of C9036, Injection, patisiran, 0.1 mg for ONPATTRO with the…

New Launch of Product Xospata

Amanda Bridges
December 2, 2018
Drugs
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Astellas is pleased to announce the product approval of XOSPATA (gilteritinib). For details on the indication for XOSPATA, please reference the attached PDF

New indication for VENCLEXTA(R) (venetoclax tablets)

Amanda Bridges
December 2, 2018
Drugs
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On November 21, 2018, VENCLEXTA® (venetoclax tablets) was approved by the US Food and Drug Administration (FDA) in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy….

FDA approves gilteritinib for relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation

FLASCO
November 28, 2018
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On November 28, 2018, the Food and Drug Administration approved gilteritinib (XOSPATA, Astellas Pharma US Inc.) for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The FDA also approved an expanded indication for a companion diagnostic, to include use with…

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

FLASCO
November 28, 2018
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The U.S. Food and Drug Administration approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy. Truxima is the first biosimiliar to be approved in the U.S. for the treatment of…

FDA approves Bayer’s larotrectinib for solid tumors with NTRK gene fusions

FLASCO
November 27, 2018
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On November 26, 2018, the Food and Drug Administration granted accelerated approval to larotrectinib (VITRAKVI, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to…

The antidiarrheal efficacy of a proprietary amino acid mixture in neuroendocrine tumor (NET) patients.

Amanda Bridges
November 26, 2018
Drugs
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Clinical data for neuroendocrine tumor patients. Entrinsic recently presented data at ASCO’s Palliative and Supportive Care in Oncology Symposium. Updated clinical results showed that 80% of NET patients reported reduction in diarrhea frequency using enterade. In addition,51% of patients reported more than 50% reduction in frequency. Diarrhea is the most common and debilitating symptom among NET cancer patients. Please…

FDA Grants Breakthrough Therapy Designation to ADCETRIS® (Brentuximab Vedotin) for Frontline Peripheral T-Cell Lymphomas

FLASCO
November 20, 2018
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FDA Grants Breakthrough Therapy Designation to ADCETRIS® (Brentuximab Vedotin) for Frontline Peripheral T-Cell Lymphomas -Designation Based on Positive Phase 3 ECHELON-2 Trial Evaluating ADCETRIS in Frontline CD30-Expressing Peripheral T-Cell Lymphomas; Data to be Presented at Upcoming American Society of Hematology Annual Meeting in December- BOTHELL, Wash. – November 15, 2018 – Seattle Genetics, Inc….

FDA approves brentuximab vedotin for previously untreated sALCL and CD30-expressing PTCL

FLASCO
November 20, 2018
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On November 16, 2018, the Food and Drug Administration approved brentuximab vedotin (ADCETRIS, Seattle Genetics Inc.) in combination with chemotherapy for previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. This is the first FDA approval for previously untreated PTCL…

FDA approves emapalumab for hemophagocytic lymphohistiocytosis

FLASCO
November 20, 2018
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On November 20, 2018, the Food and Drug Administration approved emapalumab (GAMIFANT, Novimmune SA), a monoclonal antibody that binds and neutralizes interferon gamma, for adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Approval was based on a multicenter, open-label,…

FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

FLASCO
November 12, 2018
Drugs
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On November 6, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor. In ELOQUENT-3, a randomized, open-label, phase II trial, elotuzumab…

FDA grants accelerated approval to pembrolizumab for hepatocellular carcinoma

FLASCO
November 12, 2018
Drugs
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On November 9, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. For additional information, please click here. Approval was based on KEYNOTE 224 (NCT02702414), a single-arm, multicenter trial enrolling 104 patients with hepatocellular carcinoma….

Merck is pleased to announce that KEYTRUDA in combination with carboplatin and either paclitaxel or nab-paclitaxel has been approved by the FDA for the first-line treatment of patients with metastatic squamous NSCLC

Amanda Bridges
November 9, 2018
Drugs
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KEYTRUDA is also indicated in combination with pemetrexed and platinum chemotherapy for the · First-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations KEYTRUDA is also indicated as a single agent for the · First-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (TPS ≥50%) as…

NCCN Guidelines Osimertinib (TAGRISSO) Upate

Amanda Bridges
November 7, 2018
Drugs
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Osimertinib (TAGRISSO®) is now the only preferred first-line EGFR TKI in the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®). I am excited to share with you that first-line Osimertinib (TAGRISSO®) has been elevated to preferred status in the NCCN Guidelines®, for sensitizing EGFR mutation-positive metastatic NSCLC. Osimertinib’s (TAGRISSO®) preferred status among all Category 1 recommended EGFR…

U.S. Food and Drug Administration Approves Empliciti® (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma

Amanda Bridges
November 7, 2018
Drugs
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In the ELOQUENT-3 trial, treatment with Empliciti plus pomalidomide and dexamethasone (EPd) doubled median progression-free survival and overall response rate versus pomalidomide and dexamethasone (Pd) 1 Low discontinuation rates due to adverse reactions were observed with both EPd and Pd alone 1 Empliciti, when used in combination with pomalidomide and dexamethasone, can be administered once monthly after first two cycles 1 TUESDAY,…

FDA approved Udenyca (pegfilgrastim-cbqv), a biosimilar to Neulasta (pegfilgrastim).

FLASCO
November 6, 2018
Drugs
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After previous US regulatory setbacks, Coherus Biosciences has gained FDA approval for its pegfilgrastim biosimilar, Udenyca (pegfilgrastim-cbqv). The biosimilar, referencing Neulasta, has been approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia. The company will provide more details on pricing and…

FDA approves lorlatinib for second- or third-line treatment of ALK-positive metastatic NSCLC

FLASCO
November 5, 2018
Drugs
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On November 2, 2018, the Food and Drug Administration granted accelerated approval to lorlatinib (LORBRENA, Pfizer, Inc.) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib…

Spectrum Pharmaceuticals Receives FDA Approval of KHAPZORY™ (levoleucovorin) for injection

FLASCO
October 24, 2018
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Spectrum Pharmaceuticals, Inc.(NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that the U.S. Food and Drug Administration (FDA) has approved KHAPZORY (levoleucovorin) for injection, a folate analog for three indications: • Rescue after high-dose methotrexate therapy in patients with osteosarcoma. • Diminishing…

FDA approves talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer

FLASCO
October 16, 2018
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On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib. Approval was based on…

U.S. FDA Approves VIZIMPRO® (dacomitinib) for the First-Line Treatment of Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer

Amanda Bridges
October 8, 2018
Drugs
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NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved VIZIMPRO® [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an…

FDA approves new drug for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis

FLASCO
October 8, 2018
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The US Food and Drug Administration (FDA) approved Tegsedi (inotersen), an antisense oligonucleotide (ASO) that inhibits the production of the transthyretin (TTR) protein (amyloid), for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults. This is the second FDA approved drug for hATTR. Onpattro (patisiran), was the first treatment approved for this…

FDA approves emicizumab-kxwh for hemophilia A with or without factor VIII inhibitors

FLASCO
October 5, 2018
Drugs
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On October 4, 2018, the Food and Drug Administration approved emicizumab-kxwh injection (HEMLIBRA, Genentech, Inc.) for prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (ages newborn and older) with hemophilia A (congenital factor VIII deficiency) with or without factor VIII (FVIII) inhibitors. Hemlibra was first approved in 2017 for…

2018 ASCO Advocacy Champions

FLASCO
October 3, 2018
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At the 2018 ASCO Advocacy Summit this month, members of various categories of its 2018 Advocacy Champions were announced President’s Circle – ASCO advocates who regularly participate in more than one of these advocacy activities: virtual advocacy (sending ACT Network emails); in person advocacy (conducting visits on Capitol Hill, with agency officials or at home…

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FLASCO
October 1, 2018
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the U.S. Food and Drug Administration permitted marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person’s bone marrow. “At the FDA, we’re continuing to maximize…

FDA APPROVES LIBTAYO® (CEMIPLIMAB-RWLC) AS FIRST AND ONLY TREATMENT FOR ADVANCED CUTANEOUS SQUAMOUS CELL CARCINOMA

FLASCO
October 1, 2018
Drugs
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Libtayo is the third anti-PD-1 approved in the U.S. CSCC is the second most common skin cancer in the U.S. Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for…

FDA approves dacomitinib for metastatic non-small cell lung cancer

Amanda Bridges
September 28, 2018
Drugs
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From the American Society of Clinical Oncology: In cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…

New FDA Approval for the Expanded Use of IMBRUVICA® (ibrutinib)

Amanda Bridges
September 25, 2018
Drugs
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AbbVie Announces IMBRUVICA® (ibrutinib) Plus Rituximab Approval by U.S. FDA as First Chemotherapy-Free Combination Treatment in Adults with Waldenström’s Macroglobulinemia, a Rare Type of Blood Cancer Milestone represents ninth FDA approval for IMBRUVICA in less than five years since its initial approval New approval of IMBRUVICA plus rituximab for Waldenström’s macroglobulinemia (WM) is supported by recent…

FDA granted regular approval to duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

FLASCO
September 25, 2018
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On Sept. 24, 2018, the Food and Drug Administration granted regular approval to duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. In addition, duvelisib received accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL)…

Verastem Oncology Receives FDA Approval of COPIKTRATM (duvelisib) capsules

Amanda Bridges
September 25, 2018
Drugs
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BOSTON, MA – September 24, 2018 – Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has approved COPIKTRA™, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first…

US FDA Approves New Treatment for Certain Hairy Cell Leukemia Patients

Amanda Bridges
September 18, 2018
Drugs
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We are pleased to share that AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has approved LUMOXITITM (moxetumomab pasudotox-tdfk), a first-in-class CD22-directed cytotoxin, for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two…

FDA Grants Rare Pediatric Disease Designation to Cellectar Biosciences’ CLR 131 for the Treatment of Osteosarcoma

FLASCO
September 18, 2018
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Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to CLR 131 for the treatment of osteosarcoma, a rare pediatric cancer. CLR 131 is…

FDA approves moxetumomab pasudotox-tdfk for hairy cell leukemia

FLASCO
September 13, 2018
Drugs
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On Sept. 13, 2018, the Food and Drug Administration approved moxetumomab pasudotox-tdfk (LUMOXITI, AstraZeneca Pharmaceuticals LP), a CD22-directed cytotoxin indicated for adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA). Approval was based on Study 1053 (NCT01829711) in…

FDA Approves New Treatment for the Maintenance Treatment of Opioid Dependence

FLASCO
September 10, 2018
Drugs
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Today FDA approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence. This action provides a new dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths. Cassipa was approved…

FDA Approves DELSTRIGO (Doravirine, Lamivudine, and Tenofovir Disoproxil Fumarate) for the Treatment of HIV-1 Infection in Adult Patients with no Antiretroviral Treatment History

FLASCO
September 6, 2018
Drugs
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FDA Approves DELSTRIGO (Doravirine, Lamivudine, and Tenofovir Disoproxil Fumarate) for the Treatment of HIV-1 Infection in Adult Patients with no Antiretroviral Treatment History On August 30, 2018, the U.S. Food and Drug Administration (FDA) approved DELSTRIGO, a three-drug combination of doravirine, lamivudine, and tenofovir disoproxil fumarate (TDF), to be used as a complete regimen for…

Guardant Health Announces Medicare and Cigna Coverage for the Guardant360 Assay in Non-Small Cell Lung Cancer

Amanda Bridges
September 6, 2018
Drugs
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The Guardant360® assay is now covered for all Medicare and Cigna beneficiaries with advanced NSCLC who meet certain clinical criteria. Guardant expects that these two coverage decisions will increase patient access to critical genomic information to better inform treatment. Medicare and Cigna both conducted rigorous reviews of the assay and evidence supporting its use. They evaluated dozens…

FDA Approves Ibrutinib Plus Rituximab for Waldenström’s Macroglobulinemia

FLASCO
August 29, 2018
Drugs
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The U.S. Food and Drug Administration (FDA) has approved ibrutinib (Imbruvica) plus rituximab (Rituxan) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). With this approval, the ibrutinib prescribing information now includes combination use with rituximab, representing the first and only chemotherapy-free combination treatment specifically indicated for the disease. Ibrutinib— a first-in-class Bruton’s tyrosine kinase…

Roche receives FDA approval for cobas EGFR Mutation Test v2 as companion diagnostic with IRESSA (gefitinib) in first-line treatment of patients with non-small cell lung cancer (NSCLC)

FLASCO
August 24, 2018
Drugs
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Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced approval from the U.S. Food and Drug Administration (FDA) for the cobas® EGFR Mutation Test v2 as a companion diagnostic test (CDx) with IRESSA®. A CDx test provides information that is essential for the safe and effective use of a corresponding therapeutic product. Clinical studies have demonstrated that…

FDA grants regular approval for pembrolizumab in combination with chemotherapy for first-line treatment of metastatic nonsquamous NSCLC

FLASCO
August 21, 2018
Drugs
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On August 20, 2018, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations. Pembrolizumab was previously granted accelerated approval for this indication in May 2017…

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as the First New Medication in Nearly 20 Years for Certain Patients with Previously Treated Small Cell Lung Cancer

FLASCO
August 17, 2018
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Opdivo is now the first Immuno-Oncology treatment approved for small cell lung cancer (SCLC) patients who received platinum-based chemotherapy and at least one other line of therapy Approval based on overall response rate and duration of response from the SCLC cohort of the Phase 1/2 CheckMate -032 trial 1 FRIDAY, AUGUST 17, 2018 6:59 AM EDT PRINCETON,…

FDA updates the prescribing information for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) to require the use of an FDA-approved companion diagnostic test

FLASCO
August 17, 2018
Drugs
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The FDA has updated the prescribing information for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. Two different companion diagnostic tests were approved by the FDA, one for use…

FDA approves first generic version of EpiPen

FLASCO
August 16, 2018
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The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in…

FDA approves lenvatinib for unresectable hepatocellular carcinoma

FLASCO
August 16, 2018
Drugs
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On August 16, 2018, the Food and Drug Administration approved lenvatinib capsules (Lenvima, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on an international, multicenter, randomized, open-label, non-inferiority trial (REFLECT; NCT01761266) conducted in 954 patients with previously untreated, metastatic or unresectable HCC. Patients were randomized (1:1) to receive…

FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma

FLASCO
August 9, 2018
Drugs
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U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new treatment option for patients with mycosis fungoides and is the first FDA approval of a drug specifically…

FDA Approves Iobenguane I-131 for Rare Adrenal Gland Tumors

FLASCO
August 2, 2018
Drugs
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On July 30, the U.S. Food and Drug Administration (FDA) approved iobenguane I-131 (Azedra) injection for adult and pediatric patients (12 years and older) with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic anticancer therapy. “Many patients with these ultra-rare cancers can be treated with surgery or local therapies, but there…

Shionogi & Co Ltd’s treatment for low blood-platelet count or thrombocytopenia in patients with chronic liver disease approved by FDA

FLASCO
August 1, 2018
Drugs
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On July 31, 2018, the Food and Drug Administration approved lusutrombopag (Mulpleta, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. Approval was based on two randomized, double-blind, placebo-controlled trials (L-PLUS 1 and L-PLUS 2, NCT02389621) involving 312 patients with chronic liver disease and…

FDA Discontinues Iclusig® REMS Program

FLASCO
August 1, 2018
Drugs
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FLASCO has been notified that Takeda Oncology was recently advised by the U.S. Food and Drug Administration (FDA) that the REMS (Risk Evaluation and Mitigation Strategy) communication plan for ICLUSIG® (ponatinib) is no longer required. After a comprehensive assessment, FDA determined the ICLUSIG REMS communication plan had met its goals. As a result, the REMS…

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

FLASCO
July 25, 2018
Drugs
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The U.S. Food and Drug Administration approved a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The Magtrace and Sentimag Magnetic Localization System (Sentimag System) uses magnetic detection during sentinel lymph node biopsy procedures to identify specific lymph nodes, known as sentinel lymph nodes, for surgical removal. “Sentinel…

FDA approves Nivestym (filgrastim-aafi) a biosimilar to Neupogen (filgrastim)

FLASCO
July 23, 2018
Drugs
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The FDA approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim). This is the second approved biosimilar to Neupogen approved in the U.S. Click to read the Pfizer Press Release >> Nivestym Press Release Nivestym is approved for the same indications as Neupogen, and can be prescribed by a health care professional for: • patients…

FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation

FLASCO
July 20, 2018
Drugs
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The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific…

XTANDI Significantly Extended Metastasis-Free Survival in Patients with Nonmetastatic CRPC

Amanda Bridges
July 18, 2018
Drugs
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Astellas Pharma US, Inc. and Pfizer Inc. are pleased to announce that XTANDI is now indicated for the treatment of patients with CRPC.1 PROSPER was a multinational, randomized, double-blind, placebo-controlled phase 3 study of XTANDI + LHRH therapy† in patients with nonmetastatic CRPC who had progressed on LHRH therapy.†1,2 In PROSPER, 1401 patients with nonmetastatic…

FDA expands ribociclib indication in HR-positive, HER2-negative advanced or metastatic breast cancer

FLASCO
July 18, 2018
Drugs
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On July 18, 2018, the Food and Drug Administration expanded the indication for ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) in combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. FDA also approved ribociclib in combination with fulvestrant for postmenopausal women with HR-positive, HER2-negative advanced or…

FDA Approves enzalutamide for castration-resistant prostate cancer

FLASCO
July 16, 2018
Drugs
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On July 13, 2018, the Food and Drug Administration approved enzalutamide (XTANDI, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC). This approval broadens the indicated patient population to include patients with both non-metastatic CRPC (NM-CRPC) and metastatic CRPC. Enzalutamide was previously approved for the treatment of patients with metastatic CRPC. Approval in…

FDA grants accelerated approval to ipilimumab for MSI-H or dMMR metastatic colorectal cancer

FLASCO
July 12, 2018
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On July 10, 2018, the Food and Drug Administration granted accelerated approval to ipilimumab (YERVOY®, Bristol-Myers Squibb Company Inc.) for use in combination with nivolumab for the treatment of patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with…

FDA limits the use of Tecentriq and Keytruda for some urothelial cancer patients

FLASCO
July 3, 2018
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FDA has limited the use of Tecentriq and Keytruda for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. The Agency took this action on June 19, 2018, due to decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as single therapy (monotherapy) compared to platinum-based…

FDA Approves ZEMDRI (plazomicin) for the Treatment of Patients with Complicated Urinary Tract Infections Including Pyelonephritis

FLASCO
July 2, 2018
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On June 25, 2018, the U.S. Food and Drug Administration (FDA) approved ZEMDRI (plazomicin) for the treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI) including pyelonephritis. As only limited clinical safety and efficacy data are available, reserve ZEMDRI for use in patients who have limited or no alternative…

FDA approves encorafenib and binimetinib in combination for unresectable or metastatic melanoma with BRAF mutations

FLASCO
June 27, 2018
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On June 27, 2018, the Food and Drug Administration approved encorafenib and binimetinib (BRAFTOVI and MEKTOVI, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Approval was based on a randomized, active-controlled, open-label, multicenter trial (COLUMBUS; NCT01909453) in 577…

FDA approves pembrolizumab for treatment of relapsed or refractory PMBCL

FLASCO
June 18, 2018
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On June 13, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. Approval was based on data from 53 patients with relapsed or…

New indication for VENCLEXTA(R) (venetoclax tablets)

Amanda Bridges
June 15, 2018
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On June 8, 2018, VENCLEXTA® (venetoclax tablets) was approved by the US Food and Drug Administration (FDA) for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. Genentech BioOncology® Access Solutions is your resource for access and…

FDA approves bevacizumab for ovarian cancer and pembrolizumab for large B-cell lymphoma cancer

Amanda Bridges
June 14, 2018
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Bevacizumab for Ovarian Cancer On June 13, 2018, the Food and Drug Administration approved bevacizumab (Avastin®, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. Approval was based on GOG-0218 (NCT00262847),…

FDA Approves New Treatment for Women with Advanced Ovarian Cancer After Initial Surgery

Amanda Bridges
June 14, 2018
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Today, the FDA granted approval to Avastin in combination with chemotherapy, followed by Avastin alone, for the treatment of women with advanced (stage III or IV) ovarian cancer after initial surgery. The Genentech press release including Important Safety Information is linked here. This approval marks an important milestone in ovarian cancer, as this is the…

FDA Expands Lilly’s ALIMTA® (pemetrexed) Label to Include Combination with KEYTRUDA® (pembrolizumab) and Carboplatin as First-Line Treatment for Metastatic Nonsquamous Non-Small Cell Lung Cancer, Irrespective of PD-L1 Expression

FLASCO
June 5, 2018
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New approval based on KEYNOTE-021, Cohort G1, results INDIANAPOLIS, June 5, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new indication for ALIMTA®(pemetrexed for injection) in combination with carboplatin and KEYTRUDA® (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC),…

FDA approves Fulphila (pegfilgrastim-jmdb) to help reduce the risk of infection during cancer treatment

FLASCO
June 5, 2018
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The U.S. Food and Drug Administration today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are…

FDA approves avatrombopag for thrombocytopenia in adults with chronic liver disease

FLASCO
May 24, 2018
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On May 21, 2018, the Food and Drug Administration approved avatrombopag (Doptelet, AkaRx Inc.) for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure. Approval was based on two international, identically designed, randomized, double-blind, placebo-controlled trials, ADAPT-1 and ADAPT-2. Patients (n=430) with chronic liver disease and thrombocytopenia received either avatrombopag (n=274) or…

Taiho Oncology Announces Positive Topline Results from Pivotal Phase 3 Trial of LONSURF® (trifluridine/tipiracil) in Metastatic Gastric Cancer

Amanda Bridges
May 22, 2018
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PRINCETON, N.J., May 9, 2018 – Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), and Servier, announced today that the pivotal Phase 3 (TAGS) trial evaluating LONSURF ® (trifluridine and tipiracil) plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic gastric cancer, met its primary…

Pfizer’s Biosimilar RETACRIT® (epoetin alfa-epbx) Approved by U.S. FDA

Amanda Bridges
May 22, 2018
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RETACRIT, the First U.S. Biosimilar Erythropoiesis-Stimulating Agent (ESA), Now Approved Across All Indications NEW YORK, N.Y., May 15 – Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) approved RETACRIT® (epoetin alfa-epbx), a biosimilar to Epogen® and Procrit® (epoetin alfa)1, for all indications of the reference product. RETACRIT is now…

Kymriah® (tisagenlecleucel), First-In-Class CAR-T Therapy From Novartis, Receives Second FDA Approval To Treat Appropriate R/R Patients With Large B-cell Lymphoma

Amanda Bridges
May 2, 2018
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(Novartis) May 1, 2018 – Novartis today announced the US Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for its second indication – the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL),…

CMS Proposes Changes to Empower Patients and Reduce Administrative Burden

Amanda Bridges
April 25, 2018
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Changes in IPPS and LTCH PPS would advance price transparency and interoperability On April 24, CMS proposed changes to empower patients through better access to hospital price information, improve patients’ access to their electronic health records, and make it easier for providers to spend time with their patients. The proposed rule proposes updates to Medicare…

RITUXAN HYCELA: THE SAME ANTIBODY AS RITUXAN® (rituximab), DELIVERED SUBCUTANEOUSLY WITH HYALURONIDASE HUMAN IN 5-7 MINUTES

Amanda Bridges
April 25, 2018
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All patients must first receive at least one full dose of RITUXAN (rituximab) without experiencing severe adverse reactions before starting treatment with RITUXAN HYCELA due to the higher risk of hypersensitivity and other acute reactions during the first infusion Beginning therapy with RITUXAN allows management of hypersensitivity and other administration reactions by slowing or stopping…

FDA approves osimertinib for first-line treatment of metastatic NSCLC with most common EGFR mutations

FLASCO
April 19, 2018
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On April 18, 2018, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Approval was based on a…

US FDA approves Tagrisso as 1st-line treatment for EGFR-mutated non-small cell lung cancer

FLASCO
April 19, 2018
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1st-line use of Tagrisso offers potential new standard of care Tagrisso delivered unprecedented median progression-free survival of 18.9 months versus 10.2 months compared with current standard of care AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC)…

FDA approves fostamatinib tablets for ITP

FLASCO
April 19, 2018
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On April 17, 2018, the Food and Drug Administration approved fostamatinib disodium hexahydrate tablets (TAVALISSE, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Approval was based on two identical, double-blind, placebo-controlled trials, FIT-1 (NCT02076399) and FIT-2 (NCT02076412)…

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combination as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma

Amanda Bridges
April 17, 2018
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The Opdivo + low-dose Yervoy combination is the first and only treatment to show significantly superior overall survival versus sunitinib in intermediate- and poor-risk advanced renal cell carcinoma, including a survival benefit regardless of PD-L1 expression 1,2 Treatment with Opdivo + Yervoy delivered higher objective response rates, including more complete responses, than sunitinib 1,2 In the CheckMate -214 trial, which used dosing optimized for advanced renal…

FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma

FLASCO
April 16, 2018
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On April 16, 2018, the Food and Drug Administration granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma. The approvals were based on CheckMate 214 (NCT02231749), a randomized open-label trial. Patients with previously untreated advanced RCC…

FDA approves everolimus for tuberous sclerosis complex-associated partial-onset seizures

FLASCO
April 11, 2018
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On April 10, 2018, the Food and Drug Administration approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis Pharmaceuticals Corp.) for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Everolimus is also approved for two other manifestations of TSC: TSC-associated subependymal giant cell…

FDA approves Clovis Oncology’s rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer

FLASCO
April 9, 2018
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On April 6, 2018, the Food and Drug Administration approved rucaparib (Rubraca®, Clovis Oncology Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Approval was based on ARIEL3 (NCT01968213), a randomized, double-blind,…