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FDA Issues Complete Response Letter Cosibelimab for Cutaneous Squamous Cell Carcinoma

Published: December 18, 2023

The FDA has issued a complete response letter to the biologic license application seeking the approval of cosibelimab for use in patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not eligible for curative surgery or radiation.

Source: onclive.com

Related Topics:

Kaplan MeierJames OliveroCheckpoint Therapeutics IncDrug AdministrationPrescription Drug User FeeCheckpoint TherapeuticsComplete Response LetterCutaneous Squamous Cell CarcinomaCk 301Approvability IssuesSkin Cancer