focus -WSS

focus

author：focus 2025-10-01 00:14:23 - browse：4493

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： Malaria cases in Florida and Texas: Here’s what you need to know
Next article： Insurer loopholes limit power of law against surprise medical bills

entertainment

WSS

U.K. decision on ALS drug has neurologists, advocates up in arms

Warren pushes Witty on UnitedHealth's control over physicians

Republican states more likely to report Covid vaccine side effects

Florida Supreme Court upholds state's abortion ban

Harvard scientists, with Google, unveil the most detailed brain map ever

Florida Supreme Court upholds state's abortion ban

Wikipedia

focus

This article is exclusive to STAT+ subscribers

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

hotspot

Medicare proposal to cover medical devices draws a mixed reaction

Brain MRIs reveal impact of 'toxic stress' on Black children

Over 800 arrested across France in 3rd night of riots after fatal police shooting of teen

Primary care doctor shortage won't be solved by free med school tuition

Psychedelics group wrestles with new pharma identity

First Opinion on colorectal cancer screening: letter and response

Hepatitis C has a cure — but many Americans still lack access to it

BIO to announce reorganization, senior leaders expected to depart

Medicare details structure of new drug price negotiation program

Mass General Brigham physicians react to latest merger step

hotspot

Sepsis can kill a child within hours. Here's how hospitals are fighting back

AI for drug discovery: Experts on separating hype from reality

PBM executives asked to testify by House panel

Crowdfunding for medical bills sidesteps core problem, author says

Covid silver lining: Unprecedented look at human immune system

Brain technologies pose threats that are all too real, experts warn

entertainment

entertainment

Wikipedia

knowledge