The first immunotherapy approved in the U.S. to treat head and neck cancer has failed a big test, but it’s unclear if the FDA will exercise its right to pull it from the market.
Merck (NYSE: MRK) announced late Monday that its blockbuster cancer drug pembrolizumab (Keytruda) did not meet its main goal of helping people live longer in a key trial, dubbed KEYNOTE-040. The FDA gave pembrolizumab a fast-track approval last August based on a subset of the 040 data that showed the drug was shrinking tumors. But the agency required positive results in the future, including evidence of a survival benefit over standard chemotherapy.
The approval is for patients with head and neck squamous cell carcinoma that has returned or spread to other parts of the body after treatment with chemotherapy.
The FDA approved nivolumab (Opdivo), from Merck’s top immunotherapy rival Bristol-Myers Squibb (NYSE: BMY), for the same patient population last November. Bristol’s approval was based on data that showed nivolumab improved survival by a median of 2.4 months over chemotherapy.
Merck said today that pembrolizumab’s approval for head-and-neck cancer is not in immediate danger of being revoked. “We have already discussed these data with the FDA…