Drugs

FDA Approves Ruxolitinib for Steroid-Refractory Acute GVHD

• FLASCO
• May 28, 2019
• Drugs
• No Comments

On May 24, 2019, the Food and Drug Administration approved ruxolitinib (JAKAFI®, Incyte Corporation) for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older. Approval was based on Study INCB 18424-271 (NCT02953678), an open-label, single-arm, multicenter study of ruxolitinib that enrolled 49 patients with steroid-refractory acute GVHD Grades 2 to…

FDA approves alpelisib and ruxolitinib

• FLASCO
• May 28, 2019
• Drugs
• No Comments

On May 24, 2019, the Food and Drug Administration approved alpelisib (PIQRAY, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen….

A first-line combination Rx for advanced RCC is here

• Amanda Bridges
• May 24, 2019
• Drugs
• No Comments

FDA approves avelumab plus axitinib for renal cell carcinoma

• FLASCO
• May 16, 2019
• Drugs
• No Comments

On May 14, 2019, the Food and Drug Administration approved avelumab (BAVENCIO®, EMD Serono, Inc.) in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC). Approval was based on JAVELIN Renal 101 (NCT02684006), a randomized, multicenter, open-label trial of avelumab plus axitinib in 886 patients with untreated advanced RCC regardless…

FDA approves venetoclax for CLL and SLL

• FLASCO
• May 16, 2019
• Drugs
• No Comments

On May 15, 2019, the Food and Drug Administration approved venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Approval was based on CLL14 (NCT02242942), a randomized (1:1), multicenter, open label, actively controlled trial of venetoclax in combination with obinutuzumab (VEN+G) versus obinutuzumab in…

FDA Approves ramucirumab for hepatocellular carcinoma

• FLASCO
• May 13, 2019
• Drugs
• No Comments

On May 10, 2019, the Food and Drug Administration approved ramucirumab (CYRAMZA®, Eli Lilly and Company) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib. Approval was based on REACH 2 (NCT02435433), a multinational, randomized, double-blind, placebo-controlled,…

BALVERSA™ (erdafitinib) Receives U.S. FDA Approval for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma with Certain FGFR Genetic Alterations

• Katrina Williams
• May 13, 2019
• Drugs
• No Comments

Apr 12, 2019 United States — BALVERSA is the first FGFR kinase inhibitor to receive U.S. FDA approval — Simultaneous approval of companion diagnostic intended to identify a subset of patients most likely to benefit from BALVERSA, offering a personalized treatment approach HORSHAM, Pa., April 12, 2019  — The Janssen Pharmaceutical Companies of Johnson & Johnson announced…

FDA approves ado-trastuzumab emtansine for early breast cancer

• FLASCO
• May 6, 2019
• Drugs
• No Comments

On May 3, 2019, the Food and Drug Administration approved ado-trastuzumab emtansine (KADCYLA®, Genentech, Inc.) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected based on an FDA-approved companion diagnostic for ado-trastuzumab emtansine. FDA also approved both…

Merck is pleased to announce that KEYTRUDA, in combination with axitinib, has been approved by the FDA for the first-line treatment of patients with advanced renal cell carcinoma (RCC)

• FLASCO
• May 3, 2019
• Drugs
• No Comments

Merck is pleased to announce that KEYTRUDA, in combination with axitinib, has been approved by the FDA for the first-line treatment of patients with advanced renal cell carcinoma (RCC). PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients FDA=Food and Drug Administration; PD-L1=programmed death ligand 1. Selected Safety Information…

KEYTRUDA(R) (pembrolizumab): Additional Indication

• Katrina Williams
• May 3, 2019
• Drugs
• No Comments

Merck is pleased to announce that KEYTRUDA, in combination with axitinib, has been approved by the FDA for the first-line treatment of patients with advanced renal cell carcinoma (RCC). PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients FDA=Food and Drug Administration; PD-L1=programmed death ligand 1. Selected Safety Information…

FDA approves pembrolizumab plus axitinib for advanced renal cell carcinoma

• FLASCO
• April 22, 2019
• Drugs
• No Comments

On April 19, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co. Inc.) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Approval was based on KEYNOTE 426 (NCT02853331), a randomized, multicenter, open-label trial conducted in 861 patients who had not received systemic therapy for advanced RCC….

Announcing a New Genentech Therapy

• Katrina Williams
• April 17, 2019
• Drugs
• No Comments

Genentech is excited to share the news of a new FDA-approved therapy. Adjuvant Breast Cancer  HERCEPTIN HYLECTATM (trastuzumab and hyaluronidase-oysk) is indicated for adjuvant treatment of adults with HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer: As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel With docetaxel and…

Genomic Health Introduces New Diagnostic Test Oncotype AR-V7

• Katrina Williams
• April 17, 2019
• Drugs
• No Comments

The Oncotype DX AR-V7 Nucleus Detect® Assay is the first and only nuclear-localized AR-V7 liquid biopsy blood test that can help guide treatment decisions for patients diagnosed with mCRPC who have received and failed an AR-targeted therapy such as XTANDI® (enzalutamide), ZYTIGA® (abiraterone), or ERLEADA™ (apalutamide). The Oncotype DX AR-V7 Nucleus Detect test can help…

FDA approves Genentech’s atezolizumab for extensive-stage small cell lung cancer

• FLASCO
• March 19, 2019
• Drugs
• No Comments

On March 18, 2019, the Food and Drug Administration approved atezolizumab (TECENTRIQ, Genentech Inc.) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Approval was based on IMpower133 (NCT02763579), a randomized (1:1), multicenter, double-blind, placebo-controlled trial in 403 patients with ES-SCLC who received no…

U.S. FDA Approves Pfizer’s Oncology Biosimilar Trazimera™ (Trastuzumab-QYYP), A Biosimilar To Herceptin®

• FLASCO
• March 12, 2019
• Drugs
• No Comments

Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab),1 for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 “This is an important milestone in the U.S. which both adds…

FDA approves Genentech’s atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer

• FLASCO
• March 11, 2019
• Drugs
• No Comments

On March 8, 2019, the Food and Drug Administration granted accelerated approval to atezolizumab (TECENTRIQ®, Genentech Inc.) in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area),…

FDA approves Genentech’s trastuzumab and hyaluronidase-oysk injection

• FLASCO
• February 28, 2019
• Drugs
• No Comments

On February 28, 2019, the Food and Drug Administration approved trastuzumab and hyaluronidase-oysk injection,for subcutaneous use (Herceptin Hylecta, Genentech Inc.). Herceptin Hylecta is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2‑overexpressing breast cancer.  Approval was based on two randomized trials, HannaH (NCT00950300) and SafeHER (NCT01566721). In…

FDA approves Cablivi® (caplacizumab-yhdp), the first Nanobody®-based medicine, for adults with acquired thrombotic thrombocytopenic purpura (aTTP)

• Katrina Williams
• February 26, 2019
• Drugs
• No Comments

– First medicine approved in the U.S. specifically for the treatment of aTTP, a rare blood-clotting disorder – Cablivi is the first U.S. approval for Sanofi’s new rare blood disorders franchise BRIDGEWATER, N.J., Feb. 6, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Cablivi® (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression for the…

FDA approves Taiho Oncology’s Lonsurf for recurrent, metastatic gastric and gastroesophageal junction adenocarcinoma

• FLASCO
• February 26, 2019
• Drugs
• No Comments

On February 22, 2019, the Food and Drug Administration approved trifluridine/ tipiracil tablets (LONSURF, Taiho Pharmaceutical Co., Ltd.)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a…

FDA approves Merck’s pembrolizumab for adjuvant treatment of melanoma

• FLASCO
• February 19, 2019
• Drugs
• No Comments

On February 15, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.  Approval was based on EORTC1325/KEYNOTE‑054 (NCT02362594), a randomized, double-blind, placebo-controlled, trial in 1019 patients with completely resected, stage IIIA (>1 mm lymph node metastasis), IIIB or IIIC…

Guardant360 Policy

• Amanda Bridges
• February 1, 2019
• Drugs
• No Comments

The FLASCO Clinical Practice leadership approved and signed a letter of support written to FL Blue for the Guardant360 Liquid Biopsy test in 2018. The FLASCO office was recently notified and we are now sharing the victory with you, “Florida Blue has adopted a positive medical policy for the Guardant360 Liquid Biopsy test. A very…

The clonoSEQ® Assay is now FDA-cleared and covered by Medicare for detecting and monitoring MRD in bone marrow samples from patients with multiple myeloma or B-cell ALL.

• Katrina Williams
• January 22, 2019
• Drugs
• No Comments

View our Medicare coverage press release here. For more info about clonoSEQ, including test limitations, read the Technical Summary here. ABOUT ADAPTIVE BIOTECHNOLOGIES   As a pioneer and leader in the field of immunosequencing, Adaptive Biotechnologies combines next generation sequencing (NGS) and proprietary bioinformatics to profile T-cell and B-cell receptors to drive groundbreaking research in cancer and other…

FDA Approves Exelixis’ Cabozantinib for Advanced HCC

• FLASCO
• January 15, 2019
• Drugs
• No Comments

The FDA has approved cabozantinib (Cabometyx) as a treatment for patients with hepatocellular carcinoma (HCC) who previously received sorafenib (Nexavar), according to the company developing the therapy, Exelixis. The approval was based on findings from the phase III CELESTIAL trial, in which overall survival (OS) was improved by 2.2 months with cabozantinib versus placebo. Median…

NEW FDA approval- Stemline Therapeutics

• Amanda Bridges
• December 28, 2018
• Drugs
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

 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
• No Comments

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
• No Comments

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
• No Comments

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
• Drugs
• No Comments

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
• Drugs
• No Comments

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…

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

• Amanda Bridges
• November 26, 2018
• Drugs
• No Comments

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

• FLASCO
• November 20, 2018
• Drugs
• No Comments

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
• Drugs
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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

• FLASCO
• November 5, 2018
• Drugs
• No Comments

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
• Drugs
• No Comments

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
• Drugs
• No Comments

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
• No Comments

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
• Drugs
• No Comments

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
• No Comments

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…

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
• Drugs
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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
• Drugs
• No Comments

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
• No Comments

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
• No Comments

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
• Drugs
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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
• Drugs
• No Comments

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
• No Comments

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
• Drugs
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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…