Location, Location, Location: Will Sorrento’s China-Only NSCLC Data Fly With US FDA?

Sorrento Therapeutics, Inc.’s pivotal Phase I/II trial data for abivertinib in non-small cell lung cancer (NSCLC) looks compelling and, at least on the surface, would seem to have a decent shot at supporting US Food and Drug Administration approval. But since the trial was conducted solely in China, the company is in conflict with the agency’s latest thinking on single-country studies.

In recent months, the FDA has taken a negative view toward granting approvals based on China-only studies, prompting EQRx, Inc