FDA approved the Koning Breast CT system and KBCT-guided biopsy bracket. KBCT is intended to provide three-dimensional images for diagnostic imaging of the breast.
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.
FDA expanded the approved use of Imbruvica (ibrutinib) for previously treated patients with Waldenström's macroglobulinemia. The drug received a breakthrough therapy designation for this use.
Amgen and its subsidiary Onyx Pharmaceuticals Inc. announced the submission of a supplemental New Drug Application to FDA and a Marketing Authorization Application to the European Medicines Agency for Kyprolis (carfilzomib) for Injection in relapsed multiple myeloma.
Array BioPharma Inc. reached an agreement with Novartis Pharma AG to acquire worldwide rights to encorafenib (LGX818), a BRAF inhibitor currently in phase III development. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline PLC on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals.
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.
