knowledge -WSS

knowledge

author：knowledge 2025-09-28 00:54:04 - browse：4484

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： As demand for Covid shots wanes, Moderna seeks its next success
Next article： UnitedHealth argues against case alleging wrongful AI care denials

Wikipedia

WSS

Eyeing GLP

Advocates call out 'SNL' over stereotypes, errors in sickle cell skit

CRISPR gene editing developments we’re watching in 2024

Humana’s Medicare Advantage lawsuit should be tossed, DOJ says

Fentanyl is making it harder to start addiction treatment

What STAT readers think about the FDA and patient advocacy

focus

knowledge

hotspot

ChatGPT in medicine: STAT answers readers' burning questions

Investigation reveals sickle cell patients pressured into sterilizations

Medicare details structure of new drug price negotiation program

Scrutiny of post

Wildfire smoke exposes gaps in outdoor worker protections

Bird flu surveillance in wastewater gets boost from consortium

What does generative AI mean for health care? We asked experts

Medicare Advantage beneficiaries sue Humana over algorithm use

Dobbs anniversary: the lost opportunity of abortion as health care

Study finds gene variants tied to breast cancer risk in Black women

Wikipedia

Hospitals owned by private equity see complications spike 25%

Readout Newsletter: Eli Lilly, AstraZeneca, Bristol Meyers Squibb

Questions and answers about ramping up H5N1 bird flu vaccine

Readout Newsletter: Eli Lilly, AstraZeneca, Bristol Meyers Squibb

As a primary care physician, here's how I hope to partner with AI

In Spain, a hospital brews its own CAR

Wikipedia

Wikipedia

focus

focus