The FDA on February 19, 2016 approved IBRANCE® in combination with FASLODEX® (Fulvestrant) for the treatment of women with hormone receptor (HR) positive, Human Epidermal growth factor Receptor 2 (HER2)-negative advanced or metastatic breast cancer, with disease progression following endocrine therapy. IBRANCE® capsules are a product of Pfizer, Inc.
Category: FDA Approvals
HALAVEN® (Eribulin)
The FDA on January 28, 2016 approved HALAVEN® for the treatment of patients with unresectable or metastatic Liposarcoma who have received a prior Anthracycline-containing regimen. HALAVEN® is a product of Eisai Co., Ltd.
ARZERRA® (Ofatumumab)
The FDA on January 19, 2016 approved ARZERRA® for extended treatment of patients who are in complete or partial response after at least two lines of therapy, for recurrent or progressive Chronic Lymphocytic Leukemia (CLL). ARZERRA® was previously approved for the treatment of previously untreated patients with CLL for whom Fludarabine-based therapy was considered inappropriate and also for patients with CLL refractory to Fludarabine and Alemtuzumab. ARZERRA® is a product of Novartis Pharmaceuticals Corporation.
KEYTRUDA® (Pembrolizumab)
The FDA on December 18, 2015 expanded the label to include the approval of KEYTRUDA® injection for the treatment of patients with unresectable or metastatic Melanoma. This expansion now includes the initial treatment of patients with unresectable or metastatic Melanoma with KEYTRUDA®. KEYTRUDA® is a product of Merck Sharp & Dohme Corp.
ALECENSA® (Alectinib)
The FDA granted accelerated approval to ALECENSA® capsules for the treatment of patients with Anaplastic Lymphoma Kinase (ALK)-positive metastatic Non-Small Cell Lung Cancer (NSCLC), who have progressed on or are intolerant to Crizotinib. ALECENSA® is a product of Hoffmann-La Roche Inc.
VISTOGARD® (Uridine Triacetate)
The FDA on December 11, 2015 granted approval to VISTOGARD® granules for the emergency treatment of adult and pediatric patients following a Fluorouracil or Capecitabine overdose, regardless of the presence of symptoms, or who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia), within 96 hours following the end of Fluorouracil or Capecitabine administration. VISTOGARD® is a product of Wellstat Therapeutics Corporation.
EMPLICITI® (Elotuzumab)
The FDA on November 30, 2015 approved EMPLICITI® in combination with Lenalidomide and Dexamethasone for the treatment of patients with Multiple Myeloma who have received one to three prior therapies. EMPLICITI® is a product of Bristol-Myers Squibb Company.
PORTRAZZA® (Necitumumab)
The FDA on November 24, 2015 granted approval to PORTRAZZA® in combination with Gemcitabine and Cisplatin for first-line treatment of patients with metastatic squamous Non-Small Cell Lung Cancer (NSCLC). PORTRAZZA® is not indicated for treatment of non-squamous NSCLC and is a product of Eli Lilly and Company.
OPDIVO® (Nivolumab)
The FDA on November 23, 2015 approved OPDIVO® Injection, for the treatment of advanced renal cell carcinoma, in patients who have received prior anti-angiogenic therapy. OPDIVO® is a product of Bristol-Myers Squibb Company.
MEKINIST® (Trametinib) and TAFINLAR® (Dabrafenib)
The FDA on November 20, 2015 approved MEKINIST® and TAFINLAR® for use in combination, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. MEKINIST® and TAFINLAR® are products of Novartis Pharmaceuticals Corp.