FDA granted Orphan Drug Designation to Reolysin, developed by Oncolytics Biotech Inc., for the treatment of ovarian cancer.
Merck and Bristol-Myers Squibb have agreed to transfer full responsibility for the promotion of Erbitux (cetuximab) to Merck in Japan as of May 1.
FDA granted a second breakthrough designation to the immunotherapy MPDL3280A (anti-PDL1).
FDA granted accelerated approval to Ibrance (palbociclib) to treat metastatic breast cancer.
FDA granted priority review to Yondelis (trabectedin) for the treatment of patients with advanced soft tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.
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.
