MacroGenics updates on FDA review of margetuximab for breast cancer

The FDA has notified MacroGenics (NASDAQ:MGNX) that it is no longer planning to hold an Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the Biologics License Application (BLA) for margetuximab, an investigational, monoclonal antibody that targets HER2, for the treatment of patients with pre-treated metastatic HER2-positive breast cancer in combination with chemotherapy.

The agency continues to anticipate meeting PDUFA goal date of December 18 for the application review.

https://seekingalpha.com/news/3578253-macrogenics-updates-on-fda-review-of-margetuximab-for-breast-cancer