Checkpoint Therapeutics Announces FDA Acceptance of BLA Resubmission of Cosibelimab
FDA reviews Checkpoint's cosibelimab for advanced cSCC; PDUFA date set for December 28, 2024.
Breaking News
Jul 27, 2024
Mrudula Kulkarni

Checkpoint Therapeutics, Inc. ("Checkpoint")
(Nasdaq: CKPT), a clinical-stage company specializing in immunotherapy and
targeted oncology, announced that the U.S. Food and Drug Administration (FDA)
has accepted for review the resubmitted Biologics License Application (BLA) for
cosibelimab.
This anti-PD-L1 antibody is proposed as a treatment for
adults with metastatic or locally advanced cutaneous squamous cell carcinoma
(cSCC) who are not eligible for curative surgery or radiation. The FDA has set
a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024, for
the review.
James F. Oliviero, President and CEO of Checkpoint,
expressed satisfaction with the FDA's acceptance of the BLA resubmission,
viewing it as a complete response following alignment on the resubmission
strategy. He emphasized the company’s eagerness to collaborate with the FDA to
complete the review process and potentially provide cosibelimab's dual
mechanism of action to cSCC patients.
In December 2023, the FDA issued a Complete Response Letter
(CRL) for the cosibelimab BLA, highlighting issues found during a multi-sponsor
inspection of Checkpoint’s third-party contract manufacturing organization
(CMO). These issues were the only concerns mentioned that were standing against
its approval, with no objections raised regarding the clinical data, safety, or
labelling of cosibelimab.