Early Engagement With FDA Key for Oncologic Drug Developers

Jorge Nieva, MD, ssociate professor of Clinical Medicine at the Keck School of Medicine of University of Southern California, explains how international drug developers should approach the approval application process after a biologics license application for sintilimab (Tyvyt) plus chemotherapy for the treatment of nonsquamous non–small cell lung cancer (NSCLC) did not make the cut with the FDA’s Oncologic Drugs Advisory Committee.

During the February ODAC meeting, the developer of sintilimab explained that the ORIENT-11 study was originally designed to support an approval for the combination in China, but an application was submitted to the FDA after results appeared promising and fairly similar to existing immunotherapy agents in the space.

However, ODAC voted 14 to 1 that more data were needed before the FDA could consider an application for the agent in combination with chemotherapy for patients with nonsquamous NSCLC.

Transcription:

0:07 | I think the other aspect that stood out from the meeting was that I think the message was loud and clear that the FDA needs to be engaged early. And that the other members of the committee and the FDA were not happy that the licensing application was proverbially dropped on their desk without a [United States investigation new drug application] at the institution.

0:30 | So, I think that's going to be an important message for people who are developing drugs in the future, that the approach that was taken by the applicant in this case just is not going to fly moving forward.