1. Pink Sheet
  2. >>Pathways & Standards
  3. >>Review Pathways

Oncopeptides Weighing Pepaxto Withdrawal Request

 
• By Sue Sutter

Drama continues for the multiple myeloma treatment as US FDA formally moves to pull accelerated approval. Oncopeptides anticipates making a decision on the request in the first quarter of 2023.

Oncopeptides-FDA tug of war
The tug of war between FDA and Oncopeptides over withdrawal of Pepaxto continues. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock image

In a move that should come as no surprise to many, the US FDA has requested Oncopeptides AB withdraw the NDA for Pepaxto (melphalan flufenamide), but that development is not necessarily the end of the saga for the product.

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 Review Pathways

More from Pathways & Standards

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Industry Urged To Respond To EU Expectations On Using Animal Testing Alternatives

 
• By Eliza Slawther

The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.