Fierce Pharma January 16, 2024
After crowning Keytruda as the first immunotherapy for advanced cervical cancer back in 2021, the FDA has awarded the drug another industry-first designation in an earlier stage of the tumor type. But again, the achievement was not perfect for Merck.
Thanks to a new FDA nod, Merck’s Keytruda is the first PD-1 drug to be approved in combination with chemoradiotherapy to treat patients with stage 3 to 4a cervical cancer, the New Jersey pharma giant said Friday. This marks Keytruda’s 39th indication in the U.S.
The approval, however, was narrower than expected. It came on the back of results from the Keynote-A18 trial, which showed a tumor progression benefit for the Keytruda-chemoradiation regimen in a broader patient population with earlier-stage...