The U.S. Food and Drug Administration (FDA) has approved Checkpoint Therapeutics' Unloxcyt (cosibelimab-ipdl) for the treatment of patients with advanced cutaneous squamous cell carcinoma (cSCC). This marks the first FDA approval for Checkpoint Therapeutics and positions Unloxcyt as a new treatment option in a market estimated to exceed $1 billion annually.
Unloxcyt is a PD-L1 antibody that functions by binding to the programmed death-ligand 1 (PD-L1) protein, thereby releasing the inhibitory effects of PD-L1 and enhancing the anti-tumor immune response. The drug's mechanism of action differs from PD-1 inhibitors, offering a potentially differentiated approach to immunotherapy in cSCC.
Checkpoint Therapeutics said it is currently developing a commercial launch plan for Unloxcyt. The company believes Unloxcyt offers a differentiated treatment option versus available therapies by binding to PD-L1, rather than PD-1, to release the inhibitory effects of PD-L1 as part of the anti-tumor immune response.
The FDA's decision follows the acceptance of Checkpoint's resubmitted Biologics License Application (BLA) in July, with a Prescription Drug User Fee Act (PDUFA) goal date of December 28. A Complete Response Letter (CRL) was previously issued in December 2023, citing findings from a multi-sponsor inspection of Checkpoint's third-party contract manufacturer, but the CRL did not raise concerns about the clinical data, safety, or labeling of cosibelimab.
