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.
Category: FDA Approvals
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.
NINLARO® (Ixazomib)
The FDA on November 20, 2015 approved NINLARO® in combination with Lenalidomide and Dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO® is the first approved oral proteasome inhibitor and is a product of Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
DARZALEX® (Daratumumab)
The FDA on November 16, 2015 granted accelerated approval to DARZALEX®, administered as a single agent, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a Proteasome Inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent. DARZALEX® is a product of Janssen Biotech, Inc.
TAGRISSO® (Osimertinib)
The FDA on November 13, 2015 granted accelerated approval to TAGRISSO® once daily tablets, for the treatment of patients with metastatic Epidermal Growth Factor Receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR Tyrosine Kinase Inhibitor (TKI) therapy. TAGRISSO® is a product of AstraZeneca Pharmaceuticals LP.
COTELLIC® (Cobimetinib)
The FDA on November 10, 2015 approved COTELLIC® Tablets for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation, in combination with Vemurafenib. COTELLIC® is not indicated for treatment of patients with wild-type BRAF melanoma. COTELLIC® is a product of Genentech, Inc.
IMLYGIC® (Talimogene laherparepvec)
The FDA on October 27, 2015 approved IMLYGIC®, a genetically-modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma, recurrent after initial surgery. IMLYGIC® is a product of Amgen, Inc.