- Merck & Co. will withdraw Keytruda in small-cell lung cancer, or SCLC, in the U.S. roughly a year after a confirmatory trial showed the immunotherapy, when added to chemotherapy, didn’t help patients live longer than chemo alone.
- The Food and Drug Administration granted accelerated approval to Keytruda in SCLC in 2019 based on its ability to keep tumors from spreading in patients whose disease had progressed after at least two treatments. But Keytruda had to extend lives in additional testing to retain that approval.
- The withdrawal doesn’t impact any other approved indications for Keytruda, the world’s top-selling immunotherapy and the standard of care for a majority of patients with the more common non-small cell form of lung cancer. But it’s further evidence of an apparent new push by the FDA to review drugs approved on an accelerated basis but lacking confirmatory data.
Merck withdraws Keytruda in type of lung cancer
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