Bristol's Opdivo Diversifies Options In Liver Cancer

Response rate data supports yet another supplemental approval for Opdivo in an underserved tumor type that is becoming more competitive.

FDA approved background, 3D rendering, blue street sign

The US FDA's accelerated approval of Bristol-Myers Squibb Co.'s PD-1 inhibitor Opdivo for second-line hepatocellular carcinoma paves a path for checkpoint immunotherapies in yet another traditionally underserved tumor type.

FDA announced the new approval of Opdivo Sept. 22 for use after Bayer AG's oral, kinase inhibitor mainstay Nexavar...

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

Wegovy’s Win In MASH Gives Novo A Much-Needed Edge Over Lilly

 
• By 

Just days after discontinuing a Phase III trial for a separate MASH compound, Novo Nordisk has secured the US FDA’s accelerated approval for Wegovy to treat the fatty liver disease.

Pipeline Watch: Seven Approvals And Five 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.

Tonix Ready To Revive Fibromyalgia Market With Tonyma

 
• By 

The first new drug for fibromyalgia since 2009, Tonyma is a reformulation of cyclobenzaprine intended for chronic therapy. Tonix said the drug targets non-restorative sleep.

Insmed Targets $5bn-Plus Market With Brinsupri For Bronchiectasis

 
• By 

The US FDA approved Insmed’s second product, the DPP1 inhibitor Brinsupri (brensocatib) for non-cystic fibrosis bronchiectasis. The company launched the drug immediately with a list price of $88,000 per year.

More from Scrip

Interest In PTC’s Sephience Launch Overshadows FDA’s Vatiquinone Rejection

 

PTC said it got a complete response letter for the Friedreich’s ataxia drug, with the agency asking for an additional clinical trial.

Boehringer Expands Eyecare Horizons With Palatin Collaboration

 

The German company already had four eye disease candidates in Phase II development and sees promise in Palatin’s novel melanocortin receptor modulators.

Egetis Eyes Swift US Submission For Emcitate

 
• By 

The Sweden-based firm is set for talks with the FDA on the regulatory path for its MCT8 deficiency candidate.