knowledge -WSS

knowledge

author：leisure time 2025-09-07 17:27:48 - browse：7289

CHICAGO — The Food and Drug Administration’s top oncologist reiterated that the agency doesn’t want drugmakers applying for approval with data from trials solely run in a single country such as China, but instead wants to see companies conducting studies across the world.

The comments by Richard Pazdur, director of the FDA’s Oncology Center of Excellence, came as more drugmakers report data from China, with Miami-based Summit Therapeutics earlier this week announcing that its investigational drug beat Merck’s blockbuster Keytruda in a head-to-head non-small cell lung cancer study in China.

It’s not a blanket policy, and the agency would assess each company’s submission to see how applicable the data are to the U.S. population, but in general, “I am pro multi-regional trials,” Pazdur said Friday at STAT@ASCO, STAT’s event at the American Society of Clinical Oncology annual meeting.

STAT+ Exclusive Story

Already have an account? Log in

This article is exclusive to STAT+ subscribers

Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.

Already have an account? Log in

Monthly

$39

Totals $468 per year

$39/month Get Started

Totals $468 per year

Starter

$30

for 3 months, then $39/month

$30 for 3 months Get Started

Then $39/month

Annual

$399

Save 15%

$399/year Get Started

Save 15%

11+ Users

Custom

Savings start at 25%!

Request A Quote Request A Quote

Savings start at 25%!

2-10 Users

$300

Annually per user

$300/year Get Started

$300 Annually per user

View All Plans

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

Subscribe Log In

Previous article： ChatGPT in medicine: STAT answers readers' burning questions
Next article： The world needs the new pandemic treaty

knowledge

WSS

Beyond aggravation: Constipation is an American epidemic

Leqembi, other new Alzheimer’s drugs require better biomarkers

Bubonic plague hit France in 1720. Officials dithered. Sound familiar?

Why 40% Americans with Parkinson’s don’t see a neurologist

Richard Slayman had a rejection episode of his pig kidney before leaving hospital

Protect nursing home residents from future pandemics

focus

knowledge

This article is exclusive to STAT+ subscribers

Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.

hotspot

How one medical school became remarkably diverse

Living with Fabry disease, a condition that causes chronic pain

State Dept. review finds Biden bears some blame for Afghanistan failures

Lawsuit challenges CMS nursing home minimum staffing rule

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

Richard Slayman had a rejection episode of his pig kidney before leaving hospital

Alkermes shareholders re

Threats against the LGBTQIA+ community intensifying: Department of Homeland Security

Medicare details structure of new drug price negotiation program

Some medical students still think black patients feel less pain

entertainment

Threats against the LGBTQIA+ community intensifying: Department of Homeland Security

It's time to get medical device identifiers over the finish line

A new study sees potential in DNA sequencing of infants

Congress: Prevent baby formula shortages by passing a new bill

N.Y. state detects polio case, first in the U.S. since 2013

Why 40% Americans with Parkinson’s don’t see a neurologist

focus

Wikipedia

knowledge

knowledge