1. Scrip
  2. >>New Products

Celgene, Agios Ready For Enasidenib Launch After Early Approval

 
• By Joseph Haas

Idhifa is the first treatment for AML patients with IDH2 mutations. The drug will be co-commercialized by Celgene and Agios under their 2010 collaboration and is the latter's first regulatory approval.

Digital illustration of Cancer cell in colour background

Celgene Corp. and partner Agios Pharmaceuticals Inc. are ready to quickly capitalize on FDA approval of Idhifa (enasidenib), which came nearly a month earlier than its Aug. 30 priority review user fee date, for a subset of relapsed or refractory acute myeloid leukemia patients, giving Agios its first approved drug and Celgene the initial fruits of a collaboration inked in 2010.

Idhifa, an oral, targeted inhibitor of the isocitrate dehydrogenase-2 (IDH2) enzyme, was approved Aug.1 to treat adult AML patients with...

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
Start Free Trial

Already a subscriber?

More from New Products

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

Nuvation Set For First Launch With Ibtrozi In Lung Cancer

 
• By Jessica Merrill

The US FDA approved taletrectinib for the treatment of ROS1+ NSCLC, where Nuvation hopes it will lead the category with a best-in-class position.

Pipeline Watch: ASCO Dominates 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.

Santen Sees Potential In Myopia Market After Ryjunea Approval

 
• By Kevin Grogan

The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.

More from Scrip

AstraZeneca Taps Into China’s R&D Engine With CSPC Alliance

 
• By Andrew McConaghie

After in-licensing a cardiovascular candidate last year, AstraZeneca has signed a strategic drug discovery alliance, which could generate billions of dollars in payments to the Chinese firm.

Executives On The Move: New CMOs At Instil Bio, Nkarta & Catalyst Pharma

Recent moves in the industry include changes at the top at iOnctura and Orca Bio, plus Sutro Biopharma, Tenpoint Therapeutics and Helix BioPharma get new CFOs.

In Brief: Starton Moves Low-Dose Lenalidomide To Phase IIa For Multiple Myeloma

 
• By Sushmita Panda

Study to add to safety and tolerability data for infused formulation and may help identify optimal dose for future pivotal trial.