1. Pink Sheet
  2. >>Archive

Incyte’s Jakafi Gets Broad Label, Early Approval For Myelofibrosis

 
• By Shirley Haley

Incyte Corp. hits the trifecta – a first-in-class, first-in-disease and first launch with the Nov. 16 FDA approval of Jakafi (ruxolitinib) for treatment of the progressive bone marrow cancer.

FDA cleared Incyte Corp.’s first-in class JAK1/JAK2 inhibitor ruxolitinib for treatment of myelofibrosis, making it the first approved therapy for the progressive bone marrow cancer and setting Incyte up for its first product launch, which is set to commence next week, the company announced Nov. 16.

The PDUFA date on the NDA was Dec. 3, making the approval a quick one, especially considering the application was granted a six-month priority review. In fact, the drug has been on a fast track for a while. The time between dosing of the first patient, in Aug

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 Archive

Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

More from Pink Sheet

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.

Brazil’s Drug Pricing Shake Up Calls For More Robust Evidence From Companies

 
• By Francesca Bruce

Brazil’s drug pricing authorities are planning to introduce, among other things, a new drug category for biosimilars to ensure the pricing procedures for such medicines are reflected in the official pricing framework.