NCCN Names Cosibelimab Preferred Option for CSCC
The National Comprehensive Cancer Network updated its clinical guidelines to include cosibelimab for specific skin cancer patients.
Updated on Oct. 20, 2026 in Cancer
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The NCCN has designated cosibelimab as a category 2A preferred option for patients with locally advanced cutaneous squamous cell carcinoma who are ineligible for surgery or radiation. This update follows the drug's initial FDA approval in December 2024.
Why it matters
The change follows published data showing durable, clinically meaningful responses in patients with this form of skin cancer. Providing a preferred status helps oncologists integrate the treatment into standard care pathways for complex cases.
In the locally advanced cohort of Study CK-301-101, the objective response rate was 54.8% and the complete response rate reached 25.8%. Patients in the study received an 800 mg intravenous dose of cosibelimab every two weeks.
The players
NCCN
The National Comprehensive Cancer Network is a non-profit alliance of leading cancer centers that develops clinical practice guidelines used to guide patient care.
Sun Pharma
Sun Pharma is the pharmaceutical company responsible for the development and commercialization of cosibelimab.
University of Michigan Rogel Cancer Center
The center is a leading academic institution that contributed to the clinical studies evaluating treatment efficacy for cutaneous squamous cell carcinoma.
The details
The classification pertains to the treatment of locally advanced cutaneous squamous cell carcinoma patients who cannot undergo surgery or radiation. Clinical results from Study CK-301-101 also indicated an estimated 24-month duration of response rate of 80.2%, with immune-related adverse effects reported in 27.6% of patients.
Timeline
2023: Efficacy study results published in J Immunother Cancer
December 2024: FDA approved cosibelimab for metastatic or locally advanced CSCC
2025: Cosibelimab assigned category 2A designation for metastatic CSCC
October 20, 2026: NCCN updated clinical practice guidelines for locally advanced CSCC
The Big Picture
The inclusion of cosibelimab in the NCCN Clinical Practice Guidelines follows a pattern of updating oncology protocols as new evidence from phase 1 trials matures into standard treatment options. This shifts the current approach to managing locally advanced skin cancers that were previously considered surgically unresectable.
This designation provides oncologists with a formal framework to offer cosibelimab as a preferred treatment for patients with advanced, non-surgical skin cancer. Patients should discuss potential side effects, such as the 27.6% rate of immune-related adverse events, with their healthcare team to assess suitability.
The takeaway
The NCCN update marks a milestone for patients facing cutaneous squamous cell carcinoma who are not candidates for traditional surgery or radiation. Doctors now have a clearer, evidence-backed path to utilizing this immunotherapy in the clinical setting.
Further reading
For broader information on evolving standards for skin cancer, visit the United States Cancer section.
More information
Review the official Sun Pharma news release regarding designation for technical details.
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