Health Canada granted a Class 3 Device License approval for the xTAG CYP2D6 Kit v3 genotyping assay, developed by Luminex Corporation.
FDA granted orphan drug designation to tarextumab (anti-Notch 2/3, OMP-59R5) for the treatment of both pancreatic cancer and small cell lung cancer.
The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea. If approved in the EU, ruxolitinib could provide the first targeted treatment option for these patients.
Ventana Medical Systems Inc., a member of the Roche Group, announced its FDA submission for premarket approval of the VENTANA ALK (D5F3) CDx Assay.
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.
