Amgen has high hopes for its new cancer vaccine, barreling toward global approvals with positive data in melanoma. But a narrow miss on one key endpoint could present a major hurdle, and Amgen will soon get a chance to defend the treatment before a panel of FDA advisers.
Regulatory
Genentech Submits New Drug Application to FDA for Cobimetinib And Zelboraf Combination For Advanced Melanoma Treatment
Genentech, a member of the Roche Group, submitted a New Drug Application (NDA) to the U.S Food and Drug Administration (FDA) for the use of cobimetinib in combination with Zelboraf (vemurafenib) in the treatment of patients with BRAF V600 mutation-positive advanced melanoma.
MSK Plays Critical Role in FDA Approval of New Melanoma Drug
On December 22, the US Food and Drug Administration approved a new treatment for people with melanoma that cannot be surgically removed or has metastasized, or spread, and no longer responds to other therapies. After the drug, nivolumab (Opdivo™), was shown to shrink tumors in a clinical trial, it received accelerated approval, which allows patients earlier access to promising therapies that show effectiveness during a study.
Pivotal trial of Elios melanoma vaccine to be conducted at top U.S. cancer hospitals
Elios Therapeutics, LLC recently received FDA approval of its Investigational New Drug (IND) application and its randomized phase IIb trial planned to enroll 120 stage III and IV (resected) melanoma patients to assess the ability of a personalized vaccine to prevent recurrence. The trial will be conducted at a dozen leading academic cancer research hospitals in the United States.