Blueprint Sees Blockbuster Potential For Ayvakit In Systemic Mastocytosis With ISM Nod

The US FDA gave the drug a broad label in adults with indolent SM, without restrictions for disease severity or prior treatment, and Blueprint sees a potential $1.5bn market opportunity.

Blueprint Medicines announced the approval of Ayvakit in indolent systemic mastocytosis • Source: Shutterstock

Blueprint Medicines Corporation is anticipating a gradual ramp in sales for Ayvakit (avapritinib) in indolent systemic mastocytosis (ISM), starting with those who are already diagnosed, but it sees an opportunity to reach blockbuster sales if it can address even half of the overall ISM population.

On 22 May, the US Food and Drug Administration approved Ayvakit for ISM, making it the first and only drug...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 New Products

Regeneron Wins Long-Sought FDA Nod For Lynozyfic In Myeloma

 

The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.

Pipeline Watch: Eleven Approvals And ADA Readouts Dominate

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Empty Promises: Five Drugs That Fell Short Of Their Sales Forecasts

 

Many assets underperform their pre-launch sales predictions, which can be disastrous to their developers and marketers. In this article, Scrip highlights several historic examples and the factors that influenced their poorer-than-expected performance.

Pipeline Watch: Ten Approvals And Seventeen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

BerGenBio Plumps For Oncoinvent From Long List Of 50 Suitors

 
• By 

The merger with a fellow Norwegian biotech comes a few months after its lead asset, bemcentinib, bit the dust.

In Brief: Opus Gears Up For FDA Filing In Presbyopia

 

Data from a second pivotal trial support a filing in the US for Opus Genetics’ phentolamine ophthalmic solution, to treat presbyopia.

BlissBio Goes Solo On HER2-Targeting ADC After Eisai Exit

 

BlissBio is to single-handedly move BB-1701, its eribulin-containing, HER2-targeting antibody-drug conjugate, into a global pivotal Phase II/III program for HER2-expressing, Enhertu-resistant breast cancer.