For Cancer Drugs With China-Only Data, US FDA Leaves Door Open Just A Crack

Regulatory flexibility may be warranted for diseases with low prevalence in the US, such as nasopharyngeal carcinoma, or for pediatric tumors, which are difficult to study in multi-regional trials, FDA officials said at the advisory committee review of Innovent/Lilly’s lung cancer drug sintilimab; the agency has no plans to change its regulations on evaluation of foreign clinical data.

Door crack
The US door is cracked ever so slightly for cancer drugs developed only in China. • Source: Alamy

With the recent advisory committee review of Innovent Biologics, Inc./Eli Lilly and Company’s Chinese-developed PD-1 inhibitor sintilimab, the US Food and Drug Administration sent a clear message that the regulatory door is closed to most cancer drug applications based solely on clinical trial data from a single country.

However, that same door remains open a crack for a limited group of products, such as those aimed at cancers...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA Performance Tracker

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

More from Regulatory Trackers

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.