Cemiplimab

LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation. Basal Cell Carcinoma (BCC) for the treatment of adult patients with locally advanced or metastatic BCC (laBCC or mBCC) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.

Binding of the PD-1 ligands PD-L1 and PD-L2 to the PD-1 receptor found on T cells inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Cemiplimab-rwlc is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.

Administer LIBTAYO as an intravenous infusion over 30 minutes after dilution. Metastatic and locally advanced CSCC and BCC: 350 mg every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months. Adjuvant treatment of CSCC at high risk of recurrence after surgery and radiation: 350 mg every 3 weeks for 12 weeks followed by 700 mg every 6 weeks until disease recurrence, unacceptable toxicity, or up to 48 weeks of total therapy, or 350 mg every 3 weeks until disease recurrence, unacceptable toxicity, or up to 48 weeks of total therapy. NSCLC: 350 mg every 3 weeks until disease progression or unacceptable toxicity.

None. None.

Immune-Mediated Adverse Reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue LIBTAYO based on the severity of reaction. Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue based on severity of reaction.

The following serious adverse reactions are described elsewhere in the labeling. Severe and Fatal Immune-Mediated Adverse Reactions Infusion-Related Reactions Complications of Allogeneic HSCT Most common adverse reactions (≥15%): LIBTAYO as a single agent in mCSCC or laCSCC, m BCC or laBCC, and NSCLC with high PD-L1 expression: Fatigue, musculoskeletal pain, rash, diarrhea, and anemia. LIBTAYO as a single agent in adjuvant CSCC at high risk of recurrence: Rash and pruritus. LIBTAYO in combination with platinum-based chemotherapy in NSCLC: Alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.

Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton. Do not freeze or shake. Protect from light.