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Pepaxto’s Accelerated Approval In Myeloma May Sink On OCEAN Trial's Adverse Survival Data

 
• By Sue Sutter

US FDA is reviewing confirmatory trial data that suggest a ‘detriment in survival’ with Oncopeptides’ alkylating agent in relapsed/refractory multiple myeloma and may convene its Oncologic Drugs Advisory Committee to explore continued marketing for patients who received at least four prior lines of therapy.

Ocean
Oncopeptides' melphalan flufenamide could be facing rough seas. • Source: Alamy

An adverse survival trend in the confirmatory trial for a recently approved multiple myeloma drug is once again putting the focus on the US Food and Drug Administration’s use of the accelerated approval pathway.

On 28 July, the agency alerted patients and health care providers to an increased risk of death with Oncopeptides AB’s accelerated approval drug Pepaxto (melphalan flufenamide) compared to Bristol Myers Squibb Company’s Pomalyst

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Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

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• By Sue Sutter

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