Scientists from within the industry, academia, and two U.S. national laboratories are working to streamline the process for development of cancer drugs. They are creating an open and sharable platform that integrates high-performance computing, shared biological data from public and industry sources, and emerging biotechnologies to dramatically accelerate the discovery.
Genentech announced FDA has accepted the company's supplemental Biologics License Application for Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of advanced ovarian cancer.
Immune Design said the European Medicines Agency has granted Orphan Drug Designation for G100 for the treatment of follicular non-Hodgkin's lymphoma. G100 has also been granted orphan drug designation by the FDA for the treatment of follicular non-Hodgkin's lymphoma.
Bristol-Myers Squibb Co. said FDA has accepted for priority review its supplemental Biologics License Application for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection.
Eli Lilly and Co. said FDA has granted Priority Review designation for its New Drug Application for Verzenio (abemaciclib), a cyclin-dependent kinase (CDK) 4 & 6 inhibitor.
Boehringer Ingelheim said the supplemental New Drug Application for Gilotrif (afatinib) has been accepted for filing and granted Priority Review by FDA. The application for Gilotrif is currently under review for first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 21 (L861Q), G719X, or S768I substitution mutations as detected by an FDA-approved test.
Janssen Biotech Inc. said it has submitted a New Drug Application to the FDA for apalutamide, an investigational, next generation oral androgen receptor inhibitor for men with non-metastatic castration-resistant prostate cancer. Currently, there are no FDA approved treatments for patients with non-metastatic CRPC.
FDA has cleared the first seven tesla (7T) magnetic resonance imaging device, more than doubling the static magnetic field strength available for use in the U.S.
Takeda Pharmaceutical Co. Ltd. said FDA has approved the supplemental new drug application for Alunbrig (brigatinib) 180 mg tablets.
Genentech, a member of the Roche Group, said FDA has accepted the company's supplemental Biologics License Application and granted Priority Review for Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer.
