Sun Pharma announces Unloxcyt US availability

Indian drug major Sun Pharmaceutical Industries (BSE: 524715) yesterday announced that Unloxcyt (cosibelimab-ipdl) is now available in the USA for healthcare professionals to prescribe for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

A treatment evolution in checkpoint inhibition, Unloxcyt restores the adaptive immune response and engages the innate immune system while preserving PD-L2 signaling. The US Food and Drug Administration (FDA) recently approved an updated label for Unloxcyt that reflects long-term follow-up data from the pivotal CK-301-101 clinical trial. This study showed improvements in objective response rates (including more patients who achieved a complete response) and duration of response. The safety data did not change from the original Unloxcyt label, further reinforcing a proven tolerability profile.

Sun gained rights to Unloxcyt along with its acquisition in March last year of Checkpoint Therapeutics to acquire the US immunotherapy and targeted oncology company, in a deal valued at around $355 million.