CTI's Approval Prospects For Pacritinib In Myelofibrosis Look To Be Improving

Firm publishes final data from a Phase III study showing the safety-troubled JAK2/FLT3 inhibitor performs better than Jakafi in reducing spleen size. Ongoing dose-finding study will determine the regulatory path forward.

CTI BioPharma Corp. sounds optimistic that it can find a regulatory path forward for its safety-troubled pacritinib in myelofibrosis – and market analysts seem to agree – as the Seattle biotech awaits an interim look at a dose-response study intended to illustrate the drug's risk/benefit profile, even though pacritinib missed one of the co-primary endpoints in the final data from the Phase III PERSIST-2 study.

A JAK2/FLT3 inhibitor, pacritinib had already been submitted for approval at both the US FDA and the European Medicines Agency...

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

More from Product Reviews

More from Pink Sheet

EU Medical Countermeasures Strategy Promises More AMR Pull Incentives

 

A new EU strategy to ensure access to essential medicines will boost the development of critical medical counter measures, including vaccines and therapies, according to one pharmaceutical industry group.

Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

Senate Panel Approves US CDC Director Candidate Monarez With Measles Outbreak Growing

 
• By 

The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.