Sun Pharma Secures FDA Approval for UNLOXCYT Update

The Sun Pharmaceutical Industries has secured approval from the U.S. Food and Drug Administration (FDA) for an expanded label for its immunotherapy drug UNLOXCYT (cosibelimab-ipdl).

The updated label authorizes UNLOXCYT for use in adults with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC / laCSCC) who cannot undergo curative surgery or radiation.

The decision is built on long-term follow-up from the pivotal CK-301-101 trial — a multicenter, open-label study involving 109 patients (78 with metastatic CSCC; 31 with locally advanced disease).

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Following extended observation, more than half of the participants achieved an objective response, with a notable share maintaining disease stability (14% in mCSCC and 32% in laCSCC). Importantly, the median duration of response had not been reached at data cutoff — suggesting many responses remain durable. Median time to response was rapid: 1.9 months for metastatic cases and 3.6 months for locally advanced cases.

According to Richard Ascroft, CEO, Sun Pharma North America "The longer-term results confirm that Unloxcyt represents an advancement in the available treatment options for people living with aCSCC and we support, these pivotal data highlight that more patients responded and maintained their responses to UNLOXCYT for longer than observed in the primary analysis.” The label expansion further cements UNLOXCYT’s place in the oncology?dermatology space and reflects Sun Pharma’s commitment to bringing differentiated immunotherapy solutions to patients.

Sun Pharma — which gained rights to UNLOXCYT via its acquisition of Checkpoint Therapeutics earlier this year — plans a commercial launch of UNLOXCYT in early 2026. This move positions the company to offer a promising new therapy to skin cancer patients who previously had limited options.