> ## 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.

# FDA’s Pazdur Red Flags China-based Oncology Programs
- URL: https://www.fdaweb.com/fdas-pazdur-red-flags-china-based-oncology-programs/
- Published: 2022-02-07T12:00:00.000Z
- Updated: 2026-09-14T17:31:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151095

FDA Oncology Center of Excellence director **Richard Pazdur** has taken the unusual step of calling into question the development of dozens of oncology drug development programs that rely almost exclusively on clinical data from China. Writing in a 2/4 *The Lancet* [comment piece](https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2822%2900071-7/fulltext?ref=fdaweb.com), Pazdur and oncology divsion director **Harpreet Singh** say there are at least 25 applications from China in drug development phases, planned to be submitted, or currently under review. And most of these sponsors seeking FDA approval did not seek regulatory advice under traditional milestone meetings, they say.

The first of these products goes before FDA’s Oncologic Drugs Advisory Committee 2/10, where panel members will discuss ORIENT-11, a clinical trial comparing chemotherapy plus sintilimab, a checkpoint inhibitor, with chemotherapy alone as an initial treatment for metastatic non-small-cell lung cancer (NSCLC). The BLA is sponsored by Innovent Biologics (Suzhou) which is in a global collaboration with Eli Lilly.

Pazdur and Singh have a number of concerns with the China-based trials, such as many being conducted using comparators that are not considered the current U.S. standard of care and would have difficulty in enrolling patients where advances have been approved and widely accepted by practitioners. “Frequently, these advances have not yet been approved in China at the time of trial initiation; however, they might subsequently be approved during the trial’s enrollment,” they write.

Pazdur and Singh also say they are concerned about data from a single foreign country because of its “generalizability” to American patients. They support the decades long standard of multiregional clinical trials (MRCTs) where the U.S. often was included with substantial enrollment. Now, it seems, many development programs have settled in China in what likely is a move to address Asia regulator concerns about trial diversity.

The pending applications also raise potential concerns with differences in intrinsic and extrinsic factors, and “bridging studies might not fully address concerns regarding generalizability since they are smaller, tend to be non-randomized, and rely on response rates or pharmacodynamic comparisons rather than the endpoint used in the MRCT, such as overall survival,” Pazdur and Singh write. “This regulatory flexibility in accepting bridging studies rather than mandating an additional controlled trial to establish safety and efficacy has been justified in previous decades for drugs that had few alternatives and generally fulfilled an unmet medical need.”

Because many of these applications are of the “me too” nature and most are checkpoint inhibitor antibodies, Pazdur and Singh believe the “degree of regulatory flexibility in establishing the acceptability of data from a single country and its generalizability to a new population should be balanced against the drug’s innovation." Their concern echoes a Pazdur-authored *New England Journal of Medicine* [article](https://www.nejm.org/doi/full/10.1056/NEJMp2116863?ref=fdaweb.com) in December and this characterization: “The unbridled and rapid growth of checkpoint inhibitors has led to a Wild West of drug development, featuring a stampede of commercial sponsors, clinical trials, and redundant development plans. FDA can encourage collaboration through programs such as Project Orbis and multistakeholder meetings, but it has limited ability to compel sponsors to work together. Competitive commercial interests may frequently trump cooperation.”

Additionally, Pazdur and Singh say that other factors “establishing whether a single country foreign submission would be acceptable and whether there is a need for a bridging study include the trial’s endpoint compared with endpoints used to support previous U.S. approvals, the size of the trial population, and the disease prevalence in the USA compared with the foreign region. For example, a greater degree of regulatory flexibility might be shown in a large trial investigating a disease more common in Asia, such as hepatocellular carcinoma or nasopharyngeal cancers, especially if an improvement in overall survival has been shown.”

Sponsors should design their trials to ensure patients in the U.S. have been represented, according to Pazdur and Singh. “Since trials coming from a single foreign country will generally have differing ethnic and racial representation in the population compared with the USA, additional data should be provided to ensure the generalizability of their results to the U.S. population,” they contend. “The degree of previous regulatory interaction between the USA and a foreign country might also influence the evaluation of submissions from that country. The extent of past participation in MRCTs might provide added confidence in trial conduct and data integrity. Since some clinical site inspections cannot fully capture the heterogeneity of data quality and study conduct across many clinical sites, previous participation in MRCTs and previously reported data integrity challenges might be factors in establishing the need for further trials.”