1. Scrip
  2. >>New Products

BMS Gets First Immunotherapy Approval In Neoadjuvant Lung Cancer, Quickly

 
• By Joseph Haas

Opdivo gets approved by the US FDA for neoadjuvant non-small cell lung cancer, an important new early-stage indication for the anti-PD-1 agent that cleared the agency in roughly two months.

Checkmate
Data from the CheckMate-816 study earns Bristol another indication for Opdivo • Source: Alamy

Bristol Myers Squibb Company’s Opdivo now holds the first immunotherapy approval for neoadjuvant non-small cell lung cancer (NSCLC), giving the firm an important beachhead as it focuses on expanding in the lucrative lung cancer field.

The indication for use with platinum-doublet chemotherapy for adults with resectable NSCLC in the neoadjuvant setting was based on data from the CheckMate-816 trial, and was granted by the US Food and Drug Administration late on 4 March,

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 New Products

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.

In Brief: US FDA Delay Sends Biohaven Shares Down

 
• By Andrew McConaghie

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

Strong Showing For Bayer’s Pharma Business In Uncertain Times

 
• By Kevin Grogan

As CEO Anderson backs high prices for innovative drugs in Europe

Biopharma Deals ROI Has Fallen And Market Instability Could Make It Worse

 
• By Andrew McConaghie

Rising biotech valuations mean return on investment on some deals is non-existent for big pharma, though certain strategies will improve chances of success, a new analysis has found.

More from Scrip

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.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: Trump’s executive order more rhetoric than action; industry grapples with Trump pricing plan; Hengrui set for this year’s biggest IPO; Sanofi’s exec’s advice to biotechs; and biotech deal return on investment falls.

A Short History Of MASH Deals, Culminating In GSK/Boston Pharma

 
• By Joseph Haas

Both high-profile failures and small investments that are yielding success so far characterize the dealmaking in MASH over the past 15 years or so.