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

 
• By Alaric DeArment

Sorrento plans to meet with the US FDA regarding abivertinib, but the agency’s tough stance on drug approvals based on single-country studies could thwart the company’s efforts.

Sorrento's intention to go to the FDA raise the question of how the agency will view its China-only data • Source: Shutterstock

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. to conduct new studies of the two cancer drugs...

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US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
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Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
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The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.