1. Pink Sheet
  2. >>Agency Leadership
  3. >>US FDA

Merck Files Keytruda/Chemo Combo Early With FDA In 1L Squamous Lung Cancer

 
• By Emily Hayes

Also, Bristol has filed its Opdivo/Yervoy IO combination in Europe for first-line NSCLC, including squamous and non-squamous disease, based on CheckMate 227 data; some analysts expect FDA will accept the same dataset.

Rooster Weather Vane_223028263 _1200.jpg

Merck & Co. Inc.'s early filing of the Keytruda/chemotherapy combination in first-line squamous lung cancer with the US FDA, based just on secondary endpoint response rate data, shows once again that the company is a step ahead of the PD-1 pack, though a close competitor – Bristol-Myers Squibb Co.'s Opdivo/Yervoy combo – also could be in the running.

Merck announced May 3 that it recently submitted an sBLA for its PD-1 inhibitor Keytruda (pembrolizumab) for use in combination with carboplatin-paclitaxel or

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 US FDA

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

More from Agency Leadership

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.