1. Scrip
  2. >>Therapy Areas
  3. >>Anticancer
  4. >>Immuno-oncology

Latecomer Libtayo Wins Coveted First-Line NSCLC Monotherapy Indication

 
• By Jessica Merrill

Sanofi/Regeneron's PD-1 inhibitor Libtayo joins Keytruda and Tecentriq as the only PD-1/L1s approved by the US FDA as monotherapy for first-line non-small cell lung cancer.

Blue targets and three arrows reaching the center of the first one
Libtayo joins a competitive field with a new lung cancer indication • Source: Shutterstock (Shutterstock)

Sanofi and Regeneron Pharmaceuticals, Inc. were late to market with their PD-1 inhibitor Libtayo (cemiplimab-rwlc), but they have won a coveted approval from the US Food and Drug Administration for the first-line treatment of advanced non-small cell lung cancer (NSCLC) as a monotherapy, joining only Merck & Co., Inc.'s Keytruda (pembrolizumab) and Roche Holding AG's Tecentriq (atezolizumab) with that specific indication.

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 Immuno-oncology

Bristol’s Opdivo + Yervoy Gets FDA Liver, Colorectal Cancer Nods

 
• By Joseph Haas

Bristol Myers Squibb notched two approvals in one week for its immuno-oncology combination, pitting the regimen head-to-head with Keytruda in a subset of CRC and with two combos in HCC.

BeiGene Ends Anti-TIGIT Development In Lung Cancer

 
• By Joseph Haas

BeiGene’s Phase III ociperlimab joins the list of failed TIGIT inhibitors, as candidates from Roche, Merck & Co. and others have failed late-stage studies.

Merck Gets Closer To Extending Keytruda Franchise With Subcutaneous Version

 
• By Alaric DeArment

Merck expects Keytruda to come under Medicare price controls in 2028, but an analyst said the subcutaneous version could shield revenues for the franchise.

Rybrevant/Lazcluze Survival Win Could Overcome Tagrisso’s Convenience Advantage

 
• By Alaric DeArment

J&J is confident that its bispecific antibody/kinase inhibitor combo’s overall survival win over AstraZeneca’s single-agent pill will shift the standard of care.

More from Anticancer

Epsilogen Hits Antibody Acquisition Trail With TigaTx Takeover

 
• By Kevin Grogan

Following the near-total dominance of IgG antibodies, the UK group is backing the potential of IgA and IgE-based therapies to transform cancer treatment with the purchase of US-headquartered TigaTx.

BeiGene Ends Anti-TIGIT Development In Lung Cancer

 
• By Joseph Haas

BeiGene’s Phase III ociperlimab joins the list of failed TIGIT inhibitors, as candidates from Roche, Merck & Co. and others have failed late-stage studies.

AbbVie On A STEAP Learning Curve In ADCs

 
• By Andrew McConaghie

Investing heavily in antibody-drug conjugates, AbbVie is pioneering a dual STEAP1xPSMA-targeting approach in prostate cancer, as other candidates advance.