he FDA has accepted a supplemental Biologics License Application (sBLA) for ipilimumab (Yervoy) as an adjuvant treatment of patients with stage III melanoma at high risk of recurrence following complete resection, according to Bristol-Myers Squibb, the company developing the drug. The FDA is scheduled to make a decision on adjuvant ipilimumab by October 28, 2015.
Regulatory
PD-1 Agents Vie for Frontline Spot in Melanoma Immunotherapy
New checkpoint blockade agents that target the PD-1 pathway are moving forward quickly in the melanoma treatment paradigm and likely will become a frontline immunotherapy choice for patients with advanced or metastatic disease, according to Jason J. Luke, MD, FACP, a leading researcher in the field.
Cobimetinib Receives Priority Review for Advanced Melanoma
The FDA has granted a priority review to the MEK inhibitor cobimetinib for use in combination with the BRAF inhibitor vemurafenib (Zelboraf) to treat patients with BRAF V600–positive advanced melanoma. A final approval decision will come from the FDA by August 11, 2015.
Will FDA advisers shoot down Amgen’s cancer vaccine?
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.