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Farydak Confirmatory Trial To Come Years After Accelerated Approval

 
• By Sue Sutter

Despite the agency’s preference that confirmatory trials generally be under way at the time of accelerated approval, Novartis’ panobinostat Phase III trial isn’t expected to begin for approximately three years.

FDA granted accelerated approval to Novartis AG’s HDAC inhibitor Farydak (panobinostat) for third-line treatment of multiple myeloma even though the drug’s Phase III confirmatory trial will not begin for approximately three years.

The agency’s approval letter includes two post-marketing trial requirements as a condition for accelerated approval: a Phase II multiple-dose study and a Phase III placebo-controlled trial.

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More from United States

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on impact availability.

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
• By Sue Sutter

Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

More from North America

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

Pfizer’s All-Comers CRPC Dream For Talzenna Quashed For Lack Of Biomarker-Negative Rigor

 
• By Bridget Silverman

The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.

UroGen’s Bladder Cancer Drug Draws Split Decision From US FDA Panel

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee voted 5-4 that the overall benefit-risk of UGN-102 is not favorable in patients with recurrent low grade, intermediate-risk, non-muscle invasive bladder cancer and also divided on whether randomized trials should be required for future development programs.