Adjuvant treatment of high-risk cutaneous squamous cell carcinoma (CSCC)

Active Ingredient: Cemiplimab

Indication for Cemiplimab

Population group: only adults (18 years old or older)
Therapeutic intent: Adjuvant - intent

Cemiplimab as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.

For this indication, competent medicine agencies globally authorize below treatments:

350 mg every 3 weeks for 12 weeks followed by 700 mg every 6 weeks, or 350 mg every 3 weeks for up to 48 weeks of total therapy

For:

Dosage regimens

Regimen A

Intravenous, 350 milligrams cemiplimab, once every 3 weeks, over the duration of 12 weeks. Afterwards, intravenous, 700 milligrams cemiplimab, once every 6 weeks, over the duration of up to 36 weeks.

Regimen B

Intravenous, 350 milligrams cemiplimab, once every 3 weeks, over the duration of up to 48 weeks.

Detailed description

The recommended dose of cemiplimab administered as an intravenous infusion over 30 minutes is:

  • 350 mg every 3 weeks for 12 weeks followed by 700 mg every 6 weeks, or
  • 350 mg every 3 weeks.

Treatment may be continued until disease recurrence, unacceptable toxicity, or up to 48 weeks of total therapy.

Elderly

No dose adjustment is recommended for elderly patients. Cemiplimab exposure is similar across all age groups. Data are limited in patients ≥75 years on cemiplimab monotherapy.

Dosage considerations

Cemiplimab is administered by intravenous infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on filter (0.2 micron to 5 micron pore size).

Other medicinal products should not be co-administered through the same infusion line.

Active ingredient

Cemiplimab

Cemiplimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and PD-L2. Cemiplimab potentiates T cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.

Read more about Cemiplimab

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