Thumbs down from FDA AdCom on Amgen's Lumakras

6 October 2023
amgen_hq_large

The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) yesterday found that data from a late-stage trial was not reliable enough to support traditional approval of US biotech giant Amgen's (Nasdaq: AMGN ) Lumakras (sotorasib) for adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC) for patients with a type of advanced lung cancer.

The committee was asked to vote on: Can the primary endpoint, progression-free survival (PFS) per blinded independent central review (BICR), be reliably interpreted in CodeBreaK 200? The AdCom vote was 10 against and two for.

The drug was approved by the FDA in 2021 under an accelerated pathway, with confirmatory data a condition for gaining traditional approval. The AdCom vote was 10 against and two for traditional approval.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology