The FDA on February 23, 2015 granted accelerated approval to FARYDAK® for use in combination with VELCADE® (Bortezomib) and Dexamethasone for the treatment of patients with Multiple Myeloma who have received at least two prior regimens, including VELCADE® and an immunomodulatory agent. FARYDAK® capsules are a product of Novartis Pharmaceuticals.
Category: FDA Approvals
IBRANCE® (Palbociclib)
The FDA on February 3, 2015 granted accelerated approval to IBRANCE® for use in combination with FEMARA® (Letrozole) for the treatment of postmenopausal women with Estrogen Receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative advanced Breast Cancer, as initial endocrine-based therapy for their metastatic disease. IBRANCE® is a product of Pfizer, Inc.
IMBRUVICA® (Ibrutinib)
The FDA on January 29, 2015 approved IMBRUVICA® for the treatment of patients with Waldenstrom’s Macroglobulinemia (WM). IMBRUVICA® was initially approved in November 2013 for the treatment of patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy. IMBRUVICA® also received approval in February 2014 for the treatment of Chronic Lymphocytic Leukemia (CLL) in patients who received at least one prior therapy and in July 2014 for the treatment of CLL with 17p deletion. IMBRUVICA® is an oral capsule and is a product of Pharmacyclics, Inc.
OPDIVO® (Nivolumab)
The FDA on December 22, 2014 granted accelerated approval to OPDIVO® for the treatment of patients with unresectable or metastatic melanoma and disease progression following YERVOY® (Ipilimumab) and if BRAF V600 mutation positive, a BRAF inhibitor. OPDIVO® is a product of Bristol-Myers Squibb Company.
LYNPARZA® (Olaparib)
The FDA on December 19, 2014 approved LYNPARZA® capsules as monotherapy for the treatment of patients with deleterious or suspected deleterious germline BRCA mutated (gBRCAm) (as detected by an FDA-approved test) advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy. Concurrent with this action, FDA approved the BRACAnalysis CDx® (Myriad Genetics) for the qualitative detection and classification of variants in the BRCA1 and BRCA2 genes. LYNPARZA® capsules is a product of AstraZeneca Pharmaceuticals LP.
SOMATULINE® Depot Injection (Lanreotide)
The FDA on December 16, 2014 approved SOMATULINE® Depot Injection for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. SOMATULINE® Depot Injection was previously approved for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. SOMATULINE® Depot Injection is a product of Ipsen Pharma.
CYRAMZA® (Ramucirumab)
The FDA on December 12, 2014 approved CYRAMZA® for use in combination with TAXOTERE® (Docetaxel) for the treatment of patients with metastatic Non Small Cell Lung Cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA®. CYRAMZA® injection for intravenous infusion is a product of Eli Lilly and Company.
JAKAFI® (Ruxolitinib)
The FDA on December 4, 2014 approved JAKAFI® for the treatment of patients with Polycythemia Vera (PV) who have had an inadequate response to or are intolerant of Hydroxyurea (HU). JAKAFI® is a product of Incyte Corporation.
BLINCYTO® (Blinatumomab)
The FDA on December 3, 2014 granted accelerated approval for BLINCYTO® for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (R/R ALL). BLINCYTO® is a product of Amgen Inc.
AVASTIN® (Bevacizumab)
The FDA on November 14, 2014 approved AVASTIN® in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for the treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. AVASTIN® is a product of Genentech, Inc.