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Genentech Polivy’s Benefit-Risk Profile In First-Line Lymphoma Under Scrutiny

 
• By Sue Sutter

Citing a ‘modest’ progression-free survival benefit and no improvement in overall survival in the Phase III POLARIX trial, US FDA is asking its Oncologic Drugs Advisory Committee whether polatuzumab vedotin’s current third-line indication should be expanded to first-line use in diffuse large B-cell lymphoma.

First step
Genentech is seeking to make Polivy an option in the first-line setting. • Source: Shutterstock

Citing uncertainties in progression-free survival and overall survival data from the Phase III POLARIX trial, the US Food and Drug Administration is questioning whether the benefit-risk profile of Genentech, Inc.’s Polivy (polatuzumab vedotin-piiq) is favorable in the front-line, curative intent setting for certain types of non-Hodgkin lymphomas.

Genentech is seeking a first-line indication for use of polatuzumab, in combination with R-CHP (rituximab, cyclophosphamide, doxorubicin and prednisone), for treatment of adult patients with previously untreated diffuse large B-cell...

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More from US FDA Performance Tracker

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

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More from Regulatory Trackers

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.