> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Panel Votes Down Single-Country Clinical Trial
- URL: https://www.fdaweb.com/panel-votes-down-single-country-clinical-trial/
- Published: 2022-02-10T12:00:00.000Z
- Updated: 2026-09-14T17:32:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151141

FDA’s Oncologic Drugs Advisory Committee 2/10 voted 14 to 1 that Innovent Biologics and Eli Lilly’s “me too” checkpoint inhibitor sintilimab plus chemotherapy, indicated for treating metastatic non-small-cell lung cancer (NSCLC), requires an additional clinical trial demonstrating applicability to U.S. patients and U.S. medical care. Panel members agreed with FDA concerns ([see earlier story](https://www.fdaweb.com/fda-briefing-slams-single-country-drug-data/)) outlined in briefing materials that clinical trial data (ORIENT-11) obtained from a single country (China) are not typically generalizable to the U.S. population, and that the trial design was less than optimal.

FDA Oncology Center of Excellence director **Richard Pazdur** late last week ([see story](https://www.fdaweb.com/fdas-pazdur-red-flags-china-based-oncology-programs/)) co-authored a [comment piece](https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2822%2900071-7/fulltext?ref=fdaweb.com) in *The Lancet,* calling into question the development of dozens of oncology drug development programs that rely almost exclusively on clinical data from China. Pazdur and oncology division director **Harpreet Singh** said there are at least 25 applications from China in drug development phases, planned to be submitted, or currently under review. The panel vote could be seen as the shot across the bow for other sponsors and their China-based development programs.

FDA officials used the panel meeting to steer other sponsors toward International Council of Harmonization E5 and E17 guidances, which promote the use of multiregional clinical trials (MRCTs) as the preferred approach to drug development.” FDA explained further that ICH E17 “reinforces the MRCT as the optimal method for concurrent global registration based on an emerging consensus that trials requiring international collaboration were preferred over single country trials. ORIENT-11 is not consistent with the principles outlined in ICH E17, thus does not allow for an evaluation of consistency of treatment effects across geographic regions and subpopulations. The data from ORIENT-11 are not applicable to the U.S. population and U.S. medical practice, based on the selected endpoint and control arm.”

Additionally, FDA said it was bothered by the trial design for the Innovent Biologics/Eli Lilly checkpoint inhibitor because the NSCLC treatment landscape already includes many front-line immunotherapy options “conferring advantages in overall survival (OS) whereas ORIENT-11 was powered for \[progression-free survival\] PFS. While PFS is an acceptable clinical endpoint, it is less clinically meaningful, and OS remains the preferred endpoint when it can be reasonably assessed... Overall survival was not formally tested in ORIENT-11, and approval based on a different endpoint than OS risks loss of gains in survival for U.S. patients.”