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# Priority Review for Lung Cancer BLA
- URL: https://www.fdaweb.com/priority-review-for-lung-cancer-bla/
- Published: 2025-01-13T12:00:00.000Z
- Updated: 2026-09-14T14:50:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158476

FDA has accepted for priority review an AstraZeneca and Daiichi Sankyo BLA for datopotamab deruxtecan for treating adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer who have received prior systemic therapies. The user fee review action date is expected during the third quarter, according to the companies.

The submission is based on data from the [TROPION-Lung05](https://www.clinicaltrials.gov/study/NCT04484142?term=tropion-lung05&rank=1&ref=fdaweb.com) Phase 2 trial and supported by data from the [TROPION-Lung01](https://clinicaltrials.gov/study/NCT04656652?ref=fdaweb.com) Phase 3 trial. The data demonstrated a “confirmed objective” response rate of 42.7% and a median duration of response of seven months, the companies say. The therapy’s safety profile was consistent with previous trials, and no new safety concerns were identified.

Datopotamab deruxtecan is described as a “specifically engineered” TROP2-directed DXd antibody drug conjugate.