Drugs

FDA Urges Oncopeptides to Withdraw Multiple Myeloma Drug

FDA has asked Oncopeptides to withdraw the accelerated NDA approval for multiple myeloma therapy Pepaxto (melphalan flufenamide) after a confirmatory trial (OCEAN) demonstrated a worse overall survival and failed to verify clinical benefit. The request is more evidence (see earlier story) that the agency is holding industry to timely completion of required confirmatory studies and to act accordingly when such studies fail to meet their endpoints.

Pepaxto was originally approved 2/2021, and at FDA’s request, Oncopeptides ceased marketing the therapy 10/2021, the company says. The withdrawal request comes two and a half months after FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14 to 2 against whether the benefit-to-risk profile of Pepaxto was favorable in adult patients with relapsed or refractory multiple myeloma.

In a briefing document released in advance of the meeting, FDA reviewers said the OCEAN trial did not meet the prespecified primary endpoint — progression-free survival (PFS) superiority of melphalan flufenamide compared to pomalidomide (see story). It dismissed the company’s revised PFS that showed a marginal PFS significance because it considered unconfirmed progression as events in the PFS analysis.

“The results of analyses of other efficacy endpoints such as ORR [objective response rate] and DOR [duration of response] were either not statistically significant or provided for a magnitude of effect that would not be considered clinically meaningful, the agency continued. “The results from the OCEAN trial demonstrated a detriment in overall survival for the melphalan flufenamide arm. The safety data indicate that the worse OS [overall survival] results are indicative of a safety concern and suggest a potential for harm with melphalan flufenamide.”

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