BMS' Opdivo Approval In CRC Overshadowed By Keytruda Dominance

The US FDA has approved BMS' Opdivo for previously treated patients with some forms of colorectal cancer, however direct competition from Merck's Keytruda may limit its success.

Following strong second quarter sales growth for Bristol-Myers Squibb Co.'s PD-1 inhibitor, Opdivo (nivolumab), the FDA has granted it an accelerated approval for the treatment of adults and children with microsatellite instability-high (MSI-H) and mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC), that has progressed following previous treatment with a fluoropyrimidine, oxaliplatin and irinotecan.

However, the approved indication is narrower than its prime rival, Merck & Co. Inc.'s PD-1 inhibitor Keytruda (pembrolizumab) which was additionally approved in May by the FDA for patients...

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

Bayer Has BI In Its Sights With Priority Review For HER2 Lung Cancer Drug

 
• By 

Sevabertinib gets onto the FDA's approval fast track three months after zongertinib.

Pipeline Watch: 12 Approvals And 26 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.

Boehringer’s CMO On How AI, Integrated Evidence Generation Underpin Its Ambitious Launch Plans

 

The German company has big plans for the next five years or so. Scrip speaks to its chief medical officer Lykke Hinsch Gylvin about how it is using AI and other innovative approaches to make good on its ambitions.

Pipeline Watch: Eight Approvals And Nineteen 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

Senti’s Computer-Logic Inspired Cell Therapy Shows Early Promise

 

The biotech believes its logic-gated cell therapies can get round the need for ‘clean targets’ which limit CAR-Ts and ADCs.

All Over For iTeos But Applause For Plan To Return Cash Fast

 
• By 

The company has moved quickly to wind down operations after its anti-TIGIT pact with GSK collapsed.

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By 

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now