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Genentech’s Polivy To Get US FDA Panel Review For First-Line Treatment Of Diffuse B-Cell Lymphoma

 
• By Sue Sutter

But company says the 9 March advisory committee meeting ‘currently does not have any impact’ on Polivy’s existing accelerated approval indication in the third-line setting; agency may be seeking input on the robustness of the progression-free survival benefit and uncertainties about overall survival data in the POLARIX Phase III trial in previously untreated DLBCL.  

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ODAC will scrutinize data from the POLARIX trial. • Source: Shutterstock

The US Food and Drug Administration will seek external input on a new, first-line indication for Genentech, Inc.’s Polivy (polatuzumab vedotin-piiq), which currently holds accelerated approval for third-line treatment in diffuse large B-cell lymphoma (DLBCL).

The Oncologic Drugs Advisory Committee will meet on 9 March to discuss Polivy’s benefit-risk profile in patients with previously untreated...

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More from United States

Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 
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No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
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The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.

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• By Sue Sutter

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Pink Sheet Podcast: FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-Off

 
• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.

More from North America

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.

Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption

 
• By Cathy Kelly

Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 
• By Derrick Gingery

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.