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Epizyme’s Tazemetostat Faces US FDA Doubts About Efficacy In Epithelioid Sarcoma

 
• By Sue Sutter

Low response rates in open-label, nonrandomized study raise questions about efficacy of the first-in-class EZH2 inhibitor relative to drugs currently used to treat the rare cancer, FDA says in advisory committee briefing document; retrospective natural history study also cannot be used to determine whether patients have better outcomes with tazemetostat than with available therapies.

Risks verses benefits
US FDA questions about the adequacy of efficacy evidence for tazemetostat come amid concerns about the risk of secondary malignancies. • Source: Shutterstock

The limited clinical experience and lack of reliable comparative data for Epizyme Inc.’s tazemetostat raise concerns about the drug’s efficacy in patients with epithelioid sarcoma, the US Food and Drug Administration says.

In a briefing

Advisory Committee Voting Question
  • Does the demonstrated benefit of tazemetostat outweigh the risks of the drug

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More from US FDA Performance Tracker

Keep Talking: US FDA’s Beleagured 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

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

More from Regulatory Trackers

Global Pharma Guidance Tracker - March 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

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.