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

Minimal Residual Disease Inches Closer To Supporting Myeloma Accelerated Approvals

 
• By Bridget Silverman

US FDA’s oncology advisory committee will discuss two meta-analyses supporting use of MRD as a surrogate endpoint to support accelerated approval in multiple myeloma trials.

multiple myeloma
• Source: Shutterstock

The decade-long quest to qualify minimal residual disease (MRD) as a surrogate endpoint in multiple myeloma trials could inch closer to its use to support accelerated approvals, depending on the outcome of the 12 April 2024 meeting of the US FDA’s Oncologic Drugs Advisory Committee.

Key Takeaways

  • FDA’s Oncologic Drugs Advisory Committee will vote on 12 April to determine if evidence supports the use of minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma clinical trials.

The ODAC will take a break from specific product-focused reviews with a session targeting a single voting question: “Does the...

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

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

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

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.

More from Conferences