Palmetto GBA, a national contractor that administers Medicare benefits, issued a positive coverage policy through the MolDX Program for the Decipher prostate cancer classifier developed by GenomeDx Biosciences.
FDA approved an updated version of MarginProbe, a medical device that enables real-time detection of cancer at the surface of excised tissue specimens during breast-conserving cancer surgery. MarginProbe is developed by Dune Medical Devices.
FDA approved Opdivo (nivolumab) injection 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.
Polaris Group's lead product candidate, ADI-PEG 20 (pegylated arginine deiminase), received orphan drug designations for the treatment of malignant pleural mesothelioma in the U.S. and the European Union.
Amgen and Kite Pharma entered into a strategic research collaboration and license agreement to develop and commercialize novel Chimeric Antigen Receptor T cell immunotherapies based on Kite's engineered autologous cell therapy platform and Amgen's array of cancer targets.
Taiho Oncology Inc., a subsidiary of Taiho Pharmaceutical Co. Ltd., completed its rolling New Drug Application submission to FDA for TAS-102 (trifluridine and tipiracil hydrochloride). TAS-102 is an oral combination anticancer drug under investigation for the treatment of refractory metastatic colorectal cancer.
FDA approved a supplemental biologics license application for Gazyva (obinutuzumab) in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia.
FDA granted Fast Track designation to SGX301 (synthetic hypericin) for the first-line treatment of cutaneous T-cell lymphoma.
FDA approved Lynparza (olaparib) capsules as monotherapy for the treatment of patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. FDA also approved a molecular companion diagnostic.
FDA granted accelerated approval for Blincyto (blinatumomab) for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
