Day One Springs Into Commercial Action With Ojemda Approval

The company is targeting around 200 centers that treat the vast majority of the few thousand pediatric low-grade glioma patients who are candidates for the RAF-targeting drug.

• Source: Shutterstock

Day One Biopharmaceuticals, Inc. is making an aggressive push to commercialize Ojemda (tovorafenib) following its US Food and Drug Administration accelerated approval for children with pediatric low-grade glioma (pLGG), the most common form of brain tumor in children, and intends to target the vast majority of an addressable population in the low thousands.

The FDA approved Ojemda, a type II RAF inhibitor, on 23 April for patients aged 6 months and older 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

More from New Products

Pipeline Watch: Eight Approvals And Ten 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.

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

 
• By 

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

 

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.

More from Scrip

Ireland’s Got Biopharma Talent To Keep Leading The Pack

 
• By 

The country’s life sciences investment head tells Scrip that it is business as usual for the sector despite the rumblings from across the Atlantic.

Draig Is All Fired Up To Transform Neuropsychiatric Field

 
• By 

Wales-based group launches with $140m series A.

BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties

 

Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.