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# Daiichi Sankyo, Merck Lung Cancer Therapy Gets Priority Review
- URL: https://www.fdaweb.com/daiichi-sankyo-merck-lung-cancer-therapy-gets-priority-review/
- Published: 2026-04-13T12:00:00.000Z
- Updated: 2026-09-14T13:37:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160975

FDA has accepted for priority review a Daiichi Sankyo and Merck BLA for ifinatamab deruxtecan, an investigational therapy for patients with advanced small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy. If approved, the drug — also known as I-DXd — would become the first therapy in a new class of B7-H3-directed antibody-drug conjugates for this patient population. The agency has set a review action target date of 10/10.

Small cell lung cancer accounts for roughly 12% of lung cancer cases in the U.S. and is characterized by rapid progression and poor survival outcomes, particularly in advanced stages, according to the companies. Treatment options are limited for patients whose disease worsens after initial chemotherapy.

Ifinatamab deruxtecan targets B7-H3, a protein commonly overexpressed in multiple tumor types and associated with poor prognosis. The therapy uses antibody-drug conjugate technology to deliver a chemotherapy payload directly to cancer cells.