The FDA on June 1, 2016 approved cobas EGFR Mutation Test v2, using plasma specimens, as a companion diagnostic test for the detection of exon 19 deletions or exon 21 (L858R) substitution mutations in the Epidermal Growth Factor Receptor (EGFR) gene, to identify patients with metastatic Non Small Cell Lung Cancer (NSCLC) eligible for treatment with TARCEVA® (Erlotinib). Cobas EGFR Mutation Test v2 is a product of Roche Molecular Systems, Inc.
Category: FDA Approvals
TECENTRIQ® (Atezolizumab)
The FDA on May 18, 2016 granted accelerated approval to TECENTRIQ® injection for the treatment of patients with locally advanced or metastatic Urothelial carcinoma, who have disease progression during or following Platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with Platinum-containing chemotherapy. TECENTRIQ® is a Programmed Death-ligand 1 (PD-L1) blocking antibody and is a product of Genentech, Inc.
OPDIVO® (Nivolumab)
The FDA on May 17, 2016 granted accelerated approval to OPDIVO® for the treatment of patients with classical Hodgkin Lymphoma (cHL) that has relapsed or progressed after autologous Hematopoietic Stem Cell Transplantation (HSCT) and post-transplantation ADCETRIS® (Brentuximab vedotin). OPDIVO® is marketed by Bristol-Myers Squibb company
LENVIMA® (Lenvatinib)
The FDA on May 13, 2016 approved LENVIMA® capsules in combination with AFINITOR® (Everolimus), for the treatment of advanced Renal Cell Carcinoma following one prior anti-angiogenic therapy. LENVIMA® was first approved in 2015 for the treatment of locally recurrent or metastatic, progressive, RadioActive Iodine-refractory Differentiated Thyroid Cancer. LENVIMA® is a product of Eisai, Inc.
CABOMETYX® (Cabozantinib)
The FDA on April 25, 2016 approved CABOMETYX® for the treatment of advanced Renal Cell Carcinoma, in patients who have received prior anti-angiogenic therapy. CABOMETYX® is a product of Exelixis, Inc.
VENCLEXTA® (Venetoclax)
The FDA on April 11, 2016 approved VENCLEXTA® for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy. VENCLEXTA® tablets are marketed by AbbVie, Inc. and Genentech USA, Inc.
DEFITELIO® (Defibrotide Sodium)
The FDA on March 30, 2016 approved DEFITELIO® for the treatment of adult and pediatric patients with hepatic Veno-Occlusive Disease (VOD), also known as sinusoidal obstructive syndrome, with renal or pulmonary dysfunction, following Hematopoietic Stem Cell Transplantation (HSCT). DEFITELIO® is a product of Jazz Pharmaceuticals, Inc.
XALKORI® (Crizotinib)
The FDA on March 11, 2016 approved XALKORI® capsules for the treatment of patients with metastatic Non Small Cell Lung Cancer (NSCLC) whose tumors are ROS1-positive. XALKORI® is a product of Pfizer, Inc.
AFINITOR® (Everolimus)
The FDA on February 26, 2016 approved AFINITOR® for the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease. AFINITOR® is a product of Novartis Pharmaceuticals Corporation.
GAZYVA® (Obinutuzumab)
The FDA on February 26, 2016 approved GAZYVA® for use in combination with Bendamustine followed by GAZYVA® monotherapy for the treatment of patients with Follicular Lymphoma (FL) who relapsed after, or are refractory to, a RITUXAN® (Rituximab) containing regimen. GAZYVA® was previously approved for use in combination with Chlorambucil for the treatment of patients with previously untreated Chronic Lymphocytic Leukemia. GAZYVA® injection is a product of Genentech, Inc.