By: IPP Bureau
Last updated : October 21, 2026 8:41 am
The updated recommendation adds to the drug’s existing Category 2A designation for metastatic cutaneous squamous cell carcinoma
Sun Pharmaceutical Industries has announced that UNLOXCYT (cosibelimab-ipdl) has received a National Comprehensive Cancer Network(NCCN) Category 2A recommendation for patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) who are not candidates for curative surgery or curative radiation.
The recommendation extends the drug’s existing Category 2A designation for metastatic cutaneous squamous cell carcinoma (mCSCC), which was assigned in 2025.
Approved by the US Food and Drug Administration (FDA) in 2024, UNLOXCYT is indicated for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation. It is the first and only FDA-approved programmed death-ligand 1 (PD-L1)-blocking antibody for advanced cutaneous squamous cell carcinoma (aCSCC).
The evidence supporting the updated NCCN recommendation came from the pivotal registration study, in which 55% of patients achieved an objective response, including 26% who achieved a complete response. At a median follow-up of 24.1 months, the median duration of response had not been reached, with responses ranging from 8.3 to more than 31.3 months.
Fewer than 1% of patients experienced high-grade (Grade 3–5) immune-mediated adverse reactions. No Grade 4 or Grade 5 immune-mediated adverse reactions were reported.
“The NCCN Guidelines play an important role in helping physicians evaluate appropriate treatment options for patients across different disease settings,” said Ahmad Naim, MD, Senior Vice President and North American Chief Medical Officer, Sun Pharma.
He added that the updated recommendation for laCSCC marked an important milestone, reflecting the growing body of clinical evidence supporting UNLOXCYT and increasing confidence among oncology experts in its role as a treatment option.
The NCCN is an alliance of 34 leading cancer centres in the US. Its Clinical Practice Guidelines in Oncology provide evidence-based recommendations for cancer prevention, diagnosis, evaluation and treatment.
Dr. Francis Worden, Clinical Professor of Internal Medicine at the University of Michigan Rogel Cancer Center, said the guideline update reflected the published evidence supporting the use of UNLOXCYT as a first-line treatment for laCSCC.
He highlighted the durability of responses and the low incidence of high-grade immune-mediated adverse reactions, particularly for a patient population that is predominantly elderly and often has other health conditions.
According to Dr. Worden, the drug’s mechanism of action restores adaptive immunity, engages innate immunity through antibody-dependent cellular cytotoxicity (ADCC) and preserves PD-L2 signalling, which may be associated with immune tolerance in non-tumour tissues.
The updated recommendation may also influence patient access, as NCCN guidelines inform payer coverage policies, prior authorisation criteria, institutional formularies and clinical treatment pathways.
“For patients with laCSCC—many of whom are older, medically complex, and vulnerable to treatment-related complications—access to a therapy that offers durable responses together with a low rate of high-grade imARs is especially important,” said Mark Gimbert, Senior Vice President and Head of Market and Patient Access, North America, Sun Pharma.
He added that NCCN recognition could help appropriate patients access the treatment upfront while reducing unnecessary barriers to care.