Cemiplimab is an immune checkpoint inhibitor primarily used for treating specific types of skin cancer. It activates the patient's own immune system to attack tumor cells by blocking the PD-1 pathway.

Indications for Cemiplimab

1. Primary Indications of Cemiplimab

It mainly targets advanced cutaneous squamous cell carcinoma (CSCC), and its mechanism of action enhances the immune response by inhibiting the PD-1 signaling pathway.

2. Treatment Scope and Approval Basis

(1) Cemiplimab is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not suitable for curative surgery or curative radiotherapy.

(2) This indication is based on key clinical trial data, which shows an objective response rate of 47.2%.

3. Mechanism of Action and Clinical Value

(1) As a PD-1-blocking antibody, Cemiplimab relieves the inhibition of T cells, promotes the immune system to recognize and eliminate tumor cells, and provides a new treatment option for patients with advanced CSCC.

(2) The indication of Cemiplimab is clearly focused on advanced cutaneous squamous cell carcinoma, and its mechanism and clinical data support its core position in the treatment of specific cancers.

Populations Suitable for Cemiplimab

1. Patient Selection Criteria

(1) Suitable populations include patients with metastatic or locally advanced CSCC who are unable to undergo curative surgery or radiotherapy.

(2) In clinical studies, the median age of patients was 71 years, 85% were male, and most had a history of previous treatment.

2. Considerations for Special Populations

(1) No dosage adjustment is required for elderly patients, but enhanced monitoring is necessary;

(2) It is contraindicated in pregnant women due to potential fetal risks; lactating women should discontinue breastfeeding;

(3) The safety and efficacy of Cemiplimab in pediatric patients have not been established.

Precautions for the Administration of Natalizumab

1. Contraindications and Risk Management

(1) Natalizumab should be avoided in patients with active infections or immunosuppression, as it may increase the risk of progressive multifocal leukoencephalopathy (PML).

(2) JC virus antibody status should be screened before medication administration.

2. Monitoring and Intervention Measures

(1) Regular neurological assessments and imaging examinations are required during treatment;

(2) Immediate medical attention should be sought if any new symptoms such as vision changes or cognitive impairment occur;

(3) Abrupt discontinuation of the drug should be avoided to prevent rebound effects.