FDA’s surrogate endpoint table lists those that were basis of drug approval and those may be appropriate for approval (but not yet used to support an approval). The reference guide facilitates sponsor-FDA discussions for individual development programs.
Notable updates under “Cancer: solid tumors:”
- breast cancer; neuroblastoma; muscle invasive bladder cancer (MIBC)
- Event-free survival (EFS).
- Type of Approval Appropriate for: Accelerated/Traditional.
- Mechanism of Action: Mechanism agnostic.
- metastatic non-keratinizing nasopharyngeal carcinoma (NPC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy
- Overall response rate (ORR) and duration of response (DOR).
- Type of Approval Appropriate for: Accelerated.
- Mechanism of Action: programmed death receptor-1 (PD-1)-blocking antibody
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