The European Commission approved a variation to the terms of the marketing authorization of Velcade (bortezomib), in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for blood stem-cell transplantation.
The FDA Oncologic Drugs Advisory Committee and the Cellular, Tissue and Gene Therapies Advisory Committee will jointly review talimogene laherparepvec for the treatment of patients with injectable regionally or distantly metastatic melanoma at a meeting April 29.
Roche acquired Signature Diagnostics AG, a privately held company based in Potsdam, Germany, that develops large blood plasma and tissue biobanks in multiple cancers, including colorectal and lung, which are constructed from multicenter prospective clinical studies.
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.
