focus -WSS

focus

author：explore 2025-09-30 20:18:37 - browse：17145

The FDA building -- First Opinion coverage from STAT — Adobe

The clearance of a first-of-its-kind cancer treatment made by Amgen is on shakier ground following a Food and Drug Administration advisory committee meeting Thursday.

Regulatory advisers voted 10-2 that the data on the company’s drug Lumakras, a treatment for lung cancer, could not be properly assessed. Lumakras targets a specific mutation to a protein called KRAS, which is one of the most common genetic mutations in cancer.

The vote comes as Amgen is hoping to convert a conditional approval for the drug to a full approval based on a 345-person study called CodeBreaK 200, in which Lumakras met the primary endpoint, delaying tumor growth approximately five weeks longer than the standard of care medication, docetaxel. The drug didn’t extend patients’ overall survival.

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Cancer drug shortages should be causing more outrage
Next article： Elisabeth Bik tackles the widespread issue of research misconduct

focus

WSS

Pfizer is about to make a big push in cancer. Will investors listen?

Alabama IVF ruling threatens families facing fatal genetic disease

STAT readers on older presidents, polypills, Medicare, and more

Readout Newsletter: Alnylam, Celldex, Roche, Zealand Pharma

In utero gene editing: an explainer

Readout Newsletter: Beam, Prozac, "TechBio" and more

leisure time

focus

explore

After affirmative action ruling, medical educators look to 'holistic review'

Children’s Hospital revives plan for pedestrian bridge

In age of alternative facts, a scholarly course on calling out crap

STAT readers on older presidents, polypills, Medicare, and more

New air purifier tech could be key to improving indoor air quality

NIH study of ME/CFS points to clear biological hallmarks

23andMe had bad news about my health. I wish a person had delivered it

Change Healthcare cyberattack shows risk of industry consolidation

Biden outlines 'new path' to provide student loan relief after Supreme Court rejection

Elisabeth Bik tackles the widespread issue of research misconduct

focus

Readout Newsletter: Wegovy, dialysis, Humira, Vir, and more

5 ways to address the shortage of health care workers

He's a Nobel laureate. Critics say he was misleading on Covid

Mifepristone protocols being wielded by pill's opponents in Supreme Court case

A solution to the after

With competition flaring, obesity drug hits goal in liver disease study

entertainment

focus

focus

explore