Drugs

Merck Withdraws Keytruda ‘Accelerated’ Indication

Merck has withdrawn a Keytruda (pembrolizumab) indication for treating patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The withdrawal is part of an FDA effort to clean up products/indications on the market under accelerated approval whose manufacturers failed to demonstrate their effectiveness through a required confirmatory trial. The SCLC indication withdrawal does not affect other indications for Keytruda, an anti-PD-1 therapy.

The accelerated approval on the SCLC indication was granted 6/2019 based on tumor response rate and durability of response data from Merck’s KEYNOTE-158 (cohort G) and KEYNOTE-028 (cohort C1) studies, according to Merck. In 1/2020, the company announced that its KEYNOTE-604 confirmatory Phase 3 trial for the indication met one of its dual primary endpoints of progression-free survival but did not reach statistical significance for the other primary endpoint of overall survival.

Last week, AstraZeneca found itself in the same position (see story) and withdrew an Imfinzi (durvalumab) indication for treating previously treated adult patients with locally advanced or metastatic bladder cancer. Confirmatory data did not support the indication, which was granted accelerated approval 5/2017. The withdrawal does not impact the indication outside the U.S., and does not affect other approved Imfinzi indications within or outside the U.S., the company says.

And in December, Bristol Myers Squibb withdrew an Opdivo (nivolumab) indication for treating patients with SCLC whose disease has progressed after platinum-based chemotherapy. The accelerated approval was based on Opdivo’s effect on surrogate endpoints from the Phase 1/2 CheckMate-032 trial. However, subsequent confirmatory studies in different treatment settings, CheckMate-451 and CheckMate-331, did not meet their primary endpoints of overall survival, the company said.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome