The FDA on November 5, 2014 approved CYRAMZA® for use in combination with TAXOL® (Paclitaxel), for the treatment of patients with advanced Gastric or GastroEsophageal Junction (GEJ) adenocarcinoma. CYRAMZA® was approved in April, 2014 as a single agent for the treatment of patients with advanced Gastric or GEJ adenocarcinoma refractory to or progressive following first-line therapy with platinum or fluoropyrimidine chemotherapy. CYRAMZA® injection for intravenous infusion is a product of Eli Lilly and Company.
Category: FDA Approvals
KEYTRUDA® (Pembrolizumab)
The FDA on September 4, 2014 granted accelerated approval to KEYTRUDA® 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. KEYTRUDA® is a product of Merck Sharp & Dohme Corp.
AVASTIN® (Bevacizumab)
The FDA on August 14, 2014 approved AVASTIN® for the treatment of patients with persistent, recurrent or metastatic Cervical Cancer, in combination with TAXOL® (Paclitaxel) and Cisplatin or TAXOL® and Topotecan (HYCAMTIN®). AVASTIN® is a product of Genentech, Inc.
ZYDELIG® (Idelalisib)
The FDA on July 23, 2014 granted accelerated approval to ZYDELIG® for the treatment of patients with relapsed Follicular B-cell Non-Hodgkin Lymphoma (FL) or relapsed Small Lymphocytic Lymphoma (SLL) who have received at least two prior systemic therapies. ZYDELIG® tablets are a product of Gilead Sciences, Inc.
ZYDELIG® (Idelalisib)
The FDA on July 23, 2014 approved ZYDELIG® for the treatment of patients with relapsed Chronic Lymphocytic Leukemia (CLL), in combination with Rituximab (RITUXAN®), for whom RITUXAN® alone would be considered appropriate therapy due to other co-morbidities. ZYDELIG® tablets are a product of Gilead Sciences, Inc.
BELEODAQ® (Belinostat)
The FDA on July 3, 2014 granted accelerated approval to BELEODAQ® for the treatment of patients with relapsed or refractory Peripheral T-Cell Lymphoma (PTCL). BELEODAQ® is a product of Spectrum Pharmaceuticals, Inc.
ZYKADIA® (Ceritinib)
The FDA on April 29, 2014 granted accelerated approval to ZYKADIA® for the treatment of patients with Anaplastic Lymphoma Kinase (ALK)-positive, metastatic Non-Small Cell Lung Cancer (NSCLC), with disease progression on or who are intolerant to XALKORI® (Crizotinib). ZYKADIA® capsules are a product of Novartis Pharmaceuticals Corporation.
PURIXAN® (Mercaptopurine)
The FDA on April 28, 2014 approved PURIXAN® for the treatment of patients with Acute Lymphoblastic Leukemia (ALL) as part of a combination regimen. PURIXAN® oral suspension is a product of NOVA Laboratories Limited.
SYLVANT® (Siltuximab)
The FDA on April 23, 2014 approved SYLVANT® for the treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV-) -negative and human herpes virus -8 (HHV-8) -negative. SYLVANT® injection is a product of Janssen Biotech, Inc.
CYRAMZA® (Ramucirumab)
The FDA on April 21, 2014 approved CYRAMZA® for use as a single agent, for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma, with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing chemotherapy. CYRAMZA® injection for intravenous infusion is a product of Eli Lilly and Company.