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# ODAC Meeting Signals Need for FDA Contact: Attorneys
- URL: https://www.fdaweb.com/odac-meeting-signals-need-for-fda-contact-attorneys/
- Published: 2022-03-10T12:00:00.000Z
- Updated: 2026-09-14T17:35:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151341

Two Morrison Foerster attorneys say the 2/10 meeting of the Oncologic Drugs Advisory Committee (ODAC) to consider a sintilimab application based on the ORIENT-11 trial conducted only in China sends a message to sponsors to engage early and formally with FDA if they want its approval for their drugs. In an online [post](https://www.jdsupra.com/legalnews/fda-s-loud-and-clear-message-engage-1554681/?ref=fdaweb.com), the attorneys say the committee voted 14-1 in support of a need for additional clinical trials, potentially delaying the drug’s U.S. approval for years.

ORIENT-11 is a Phase 3 trial to assess the safety and efficacy of sintilimab in combination with pemetrexed and platinum chemotherapy as a first-line treatment for patients with advanced or metastatic nonsquamous non-small-cell lung cancer. The committee majority said the trial was not generalizable to the U.S. population because **(1)** the patient demographics in ORIENT-11 do not reflect the diverse U.S. population; **(2)** the study endpoint and comparator arm were not the standard of care for U.S. medical practice; **(3)** the consent forms should have been updated when pembrolizumab was approved by the Chinese regulatory agency seven months after study initiation; and **(4)** the inspections were too limited in scope to assess trial conduct and data integrity.

FDA has said it will be flexible in applying the regulation governing trials conducted only in foreign countries and thus the ODAC meeting provides valuable insights for sponsors that seek FDA approval based on a foreign-only clinical strategy, the attorneys write.

The post covers early engagement with FDA, data integrity, diversity in trial subjects, and human subject protections.

“Informal communication can be a great way to learn the current thinking of the agency,” the attorneys write, “however, it is critically important to follow up with a formal meeting to receive formal regulatory advice. Second, FDA clearly favors MRCTs (multi-region clinical trials) as a way to promote diversity and data integrity. It could be very beneficial to engage with study sites that have a known reputation with FDA, such as prior involvement in FDA-regulated clinical studies. Last, but not least, all clinical studies need to be conducted ethically, with informed consent as the cornerstone of all research ethics. Sponsors need to put in the utmost effort to ensure that patients are fully informed throughout the study.”