Libtayo Gains Approval for First-Line NSCLC With Chemotherapy

Regeneron's PD-1 inhibitor was approved by the US FDA in combination with chemotherapy for first-line treatment of advanced non-small cell lung cancer.

lung cancer
Regeneron's Libtayo added a new lung cancer indication • Source: Shutterstock

Regeneron Pharmaceuticals, Inc.'s PD-1 inhibitor Libtayo (cemiplimab) was late to the market, but has added a new approval for first-line non-small cell lung cancer (NSCLC) in combination with platinum-based chemotherapy, a valuable indication that will make it more competitive with the PD-1/L1 inhibitor market leader, Merck & Co., Inc.'s Keytruda (pembrolizumab).

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

J&J’s Imaavy Approval Is The Starting Line For Pipeline-In-A-Product Strategy

 

The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.

Pipeline Watch: Five Approvals And One Phase III Readout

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.

Merck KGaA Seals SpringWorks Buy

 
• By 

The German group is paying $3.9bn to get hold of the US firm and its two approved products.

Akeso Wins US Approval For PD-1 Antibody In NPC, Partly On US Data

 

Akeso’s penpulimab will be the second to hit the US market for nasopharyngeal carcinoma, but the first to win FDA approval for the indication based on clinical findings in US patients.

More from Scrip

Zelluna Believes Its TCR Tech Can Unlock Natural Killer Cell Potential

 

While CAR-NKs have pivoted towards autoimmune disease, the Norwegian biotech believes its unique platform can deliver in oncology

AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
• By 

The triple therapy improves lung function in the Phase III KALOS and LOGOS studies

Transient FY26 For Syngene But Momentum In China +1 Projects

 

As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.