Drugs

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…

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
• No Comments

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
• No Comments

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
• No Comments

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
• No Comments

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
• Drugs
• No Comments

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
• Drugs
• No Comments

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
• Drugs
• No Comments

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
• Drugs
• No Comments

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
• Drugs
• No Comments

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
• Drugs
• No Comments

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
• Drugs
• No Comments

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
• Drugs
• No Comments

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

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

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
• Drugs
• No Comments

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
• Drugs
• No Comments

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
• Drugs
• No Comments

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
• Drugs
• No Comments

(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
• Drugs
• No Comments

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
• Drugs
• No Comments

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…

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

• FLASCO
• April 19, 2018
• Drugs
• No Comments

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
• Drugs
• No Comments

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
• Drugs
• No Comments

 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
• Drugs
• No Comments

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
• Drugs
• No Comments

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
• Drugs
• No Comments

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,…

FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia

• FLASCO
• March 30, 2018
• Drugs
• No Comments

On March 29, 2018, the Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Approval was based on the open…

Nilotinib Approved to Treat Pediatric Patients with Leukemia

• FLASCO
• March 26, 2018
• Drugs
• No Comments

The FDA approved an expanded indication for nilotinib (Tasigna) as a first- and second-line treatment for pediatric patients 1 year and older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP), according to a press release. Nilotinib is currently indicated to treat both adults and pediatric patients with newly-diagnosed Ph+ CML-CP. It is…

NCCN Recommends Regorafenib Dose Escalation in Metastatic CRC

• Amanda Bridges
• March 20, 2018
• Drugs
• No Comments

The NCCN guidelines were updated. CRC now includes the new dose escalation for Stivarga as a result of the ReDos study.  Read more at OncLive.com here http://www.onclive.com/web-exclusives/nccn-recommends-regorafenib-dose-escalation-in-metastatic-crc.

FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

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

The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. “Today’s approval represents an improvement in the initial treatment regimens of advanced Hodgkin lymphoma that were introduced into clinical practice more than 40 years ago,”…

FDA Approves sBLA Updating Nivolumab Dosing Schedule Across Indications

• FLASCO
• March 8, 2018
• Drugs
• No Comments

On March 6, Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the nivolumab (Opdivo) dosing schedule to include 480 mg infused every 4 weeks for a majority of approved indications. This approval will provide health-care professionals the flexibility to customize patient care with the option of using the…

FDA Approval of New Indication for Verzenio™

• Amanda Bridges
• March 2, 2018
• Drugs
• No Comments

February 26, 2018 – The US Food and Drug Administration (FDA) approved a new indication for Verzenio™ (abemaciclib 50, 100, 150, 200 mg tablets). See below for the Indication and Important Safety Information and click to access the full Prescribing Information for Verzenio.    Dosing Regimen Tablet Strength Quantity NDC* Days of Therapy per Pack Verzenio 7-Day Dose…

FDA approves Lilly’s abemaciclib as initial therapy for HR-positive, HER2-negative metastatic breast cancer

• FLASCO
• February 27, 2018
• Drugs
• No Comments

On February 26, 2018, the Food and Drug Administration approved abemaciclib (VERZENIO™, Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Approval was based on MONARCH 3, a randomized (2:1), double-blinded,…

FDA expands approval of AstraZeneca’s Imfinzi to reduce the risk of non-small cell lung cancer progressing

• FLASCO
• February 19, 2018
• Drugs
• No Comments

The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). “This is the first treatment approved for stage III…

The U.S. Food and Drug Administration approved Janssen’s Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant).

• FLASCO
• February 14, 2018
• Drugs
• No Comments

The U.S. Food and Drug Administration approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer. “The FDA evaluates a variety of methods that measure a drug’s…

FDA approves new treatment for certain digestive tract cancers

• FLASCO
• January 28, 2018
• Drugs
• No Comments

The U.S. Food and Drug Administration  approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult…

FDA approves new indication for Gilotrif® in EGFR mutation-positive NSCLC

• Amanda Bridges
• January 18, 2018
• Drugs
• No Comments

FDA Warns About Anaphylaxis, Anaphylactic Shock With Use Of Rolapitant In Patients With Cancer.

• FLASCO
• January 18, 2018
• Drugs
• No Comments

A warning about anaphylaxis, anaphylactic shock, and other hypersensitivity reactions occurring with the use of rolapitant (Varubi, Tesaro Inc) in patients with cancer has been highlighted by the US Food and Drug Administration in a MedWatch bulletin. Rolapitant is a substance/ neurokinin receptor antagonist indicated for the prevention of delayed nausea and vomiting associated with cancer…

FDA Approves Addition Of Overall Survival Data To KYPROLIS® (carfilzomib) Label

• FLASCO
• January 18, 2018
• Drugs
• No Comments

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for KYPROLIS® (carfilzomib). Data added to the label demonstrated that KYPROLIS and dexamethasone (Kd) reduced the risk of death by…

Teva Announces U.S. FDA Approval of TRISENOX® (arsenic trioxide) Injection for First Line Treatment of Acute Promyelocytic Leukemia

• FLASCO
• January 16, 2018
• Drugs
• No Comments

Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the use of TRISENOX® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. The approval was based on…

FDA broadens afatinib indication to previously untreated, metastatic NSCLC with other non-resistant EGFR mutations

• FLASCO
• January 16, 2018
• Drugs
• No Comments

On January 12, 2018, the Food and Drug Administration granted approval to afatinib (Gilotrif, Boehringer Ingelheim Pharmaceutical, Inc.) for a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. Approval was based on demonstration…

LYNPARZA® (olaparib) Receives US FDA Approval for a New Indication

• Amanda Bridges
• January 15, 2018
• Drugs
• No Comments

We are excited to announce on January 12, 2018, the FDA approved a new indication for the PARP inhibitor, LYNPARZA® (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) who have been previously treated with chemotherapy in the neoadjuvant, adjuvant…

FDA approves AstraZeneca’s aparib for germline BRCA-mutated metastatic breast cancer

• FLASCO
• January 12, 2018
• Drugs
• No Comments

On January 12, 2018, the Food and Drug Administration granted regular approval to olaparib tablets (Lynparza, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic…

Announcing a New Indication for a PERJETA

• FLASCO
• January 8, 2018
• Drugs
• No Comments

Genentech is excited to share the news of the FDA approval of PERJETA in combination with trastuzumab and chemotherapy as: ·       Neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast…

FDA Approves Denosumab (Xgeva) for the Prevention of Skeletal-Related Events in Patients With Multiple Myeloma

• FLASCO
• January 8, 2018
• Drugs
• No Comments

The FDA has approved denosumab (Xgeva) for the prevention of skeletal-related events (SREs) in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor. The approval is based on data from the phase III 482 study, which were presented at the 16th International Myeloma Workshop in New Delhi. In the trial,…

FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response

• FLASCO
• December 26, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotinib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML)….

Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab)

• Amanda Bridges
• December 21, 2017
• Drugs
• No Comments

Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease. Please click here for an announcement from Bristol-Myers Squibb.

The FDA Approved Perjeta® (pertuzumab)

• Amanda Bridges
• December 21, 2017
• Drugs
• No Comments

The FDA recently approved Perjeta® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence. The Genentech press release including Important Safety Information is linked here. This approval is important because: It is based on results of the Phase…