The accelerated approval pathway was first introduced in 1992 in response to the HIV pandemic and was updated in 2012 to allow conditional nods based on surrogate clinical endpoints that are “reasonably likely” to predict clinical benefit. Keytruda rounds out the rule of three, pointing to a possible clean out at the FDA to finally remove accelerated nods doled out based on surrogate markers but later contradicted in confirmatory studies-or those that simply didn’t honor their post-marketing data commitments. RELATED: Merck's Keytruda misses key mark in small cell lung cancer trial, dashing big expansion hopes The study was supposed to serve as the confirmatory trial for the original SCLC nod. The Keynote-604 trial found that adding Keytruda to chemotherapy couldn’t outdo solo chemo at prolonging the lives of newly diagnosed patients with extensive-stage SCLC. 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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