The US Food and Drug Administration’s Oncologic Drugs Advisory Committee voted unanimously in favor of delaying an approval decision on Merck & Co., Inc.’s Keytruda (pembrolizumab) for treatment of high-risk, early-stage triple-negative breast cancer, siding with the agency’s position that modeling cannot substitute for completed clinical trial data.
The 10-0 panel vote on 9 February was also a reminder of the limits FDA has laid out around the...