![]() ![]() ![]() ![]() Keytruda won accelerated approval in SCLC in June 2019 based on tumor response rate and duration of response data from the phase 1 Keynote-028 trial and phase 2 Keynote-158.īut, last January, the drug flunked its phase 3 in that form of lung cancer. Just a few days ago, AstraZeneca did the same for its PD-L1 drug Imfinzi, but in previously treated bladder cancer. ![]() BMS pulled Opdivo at the end of 2020, also in SCLC. Indeed, the Keytruda withdrawal followed a similar move by Bristol Myers Squibb for its rival PD-1 inhibitor Opdivo. Merck said it made the decision after talking to the FDA, and the retraction process is expected to be complete over the coming weeks.Īs Merck put it, its call to account at the FDA is “part of an industrywide evaluation of indications based on accelerated approvals that have not yet met their post-marketing requirements.” indication in third-line SCLC, the company said Monday. The New Jersey pharma is voluntarily withdrawing Keytruda’s U.S. ![]()
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