1. Pink Sheet
  2. >>Regulatory Trackers
  3. >>US FDA Performance Tracker

Genentech’s Polivy Gets US FDA Panel Nod For First-Line Use In Large B-Cell Lymphoma

 
• By Sue Sutter

Advisory committee members were swayed by a progression-free survival benefit, and the reduction in salvage therapies, with a polatuzumab-containing regimen relative to the highly effective standard of care in the POLARIX trial.

Thumbs up
An expanded indication for Polivy got a thumbs-up from ODAC. • Source: Shutterstock

Genentech, Inc.’s antibody drug conjugate Polivy (polatuzumab vedotin-piiq) has a favorable benefit-risk profile for front-line treatment of diffuse large B-cell lymphoma and should be considered an option, but not necessarily a replacement, for the current highly effective standard of care, US Food and Drug Administration advisory committee members said on 9 March.

Eleven of 13 members of the Oncologic Drugs Advisory Committee looked favorably upon the results from POLARIX, a Phase III...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from US FDA Performance Tracker

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
• By Bridget Silverman

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 
• By Bridget Silverman

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
• By Bridget Silverman

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

More from Regulatory Trackers

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US.

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.