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# FDA Rejects Lilly BLA on Me-too PD-1 Inhibitor
- URL: https://www.fdaweb.com/fda-rejects-lilly-bla-on-me-too-pd-1-inhibitor/
- Published: 2022-03-24T12:00:00.000Z
- Updated: 2026-09-14T17:37:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151450

FDA has issued Eli Lilly and Innovent Biologics a complete response letter on its BLA for sintilimab injection, a me-too PD-1 inhibitor for use in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer (NSCLC). The letter calls for an additional clinical trial which is consistent with statements made last month by FDA Oncology Center of Excellence director **Richard Pazdur** who called into question oncology drug development programs that rely almost exclusively on clinical data from China ([see earlier story](https://www.fdaweb.com/fdas-pazdur-red-flags-china-based-oncology-programs/)).

Pazdur’s position was also validated by a 2/10 advisory committee meeting. Panel members said the submission should require an additional clinical trial demonstrating applicability to U.S. patients and U.S. medical care. They 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’s letter specifically requested a multiregional clinical trial comparing standard of care therapy for first line metastatic NSCLC to sintilimab with chemotherapy utilizing a non-inferiority design with an overall survival endpoint, according to the company. “Along with Innovent, Lilly is assessing next steps for the sintilimab program in the U.S.,” it says.