This medication requires a valid prescription. Please refer to the ‘Prescription Guide’ for details.

Note: We can assist only if the medicine is unavailable in your country.”

Libtayo (cemiplimab-rwlc)

General Description:

Libtayo (cemiplimab-rwlc) is an immunotherapy used to treat specific cancers, including cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), and non-small cell lung cancer (NSCLC). As a PD-1 inhibitor, it works by blocking the PD-1/PD-L1 pathway, allowing the immune system to better recognize and attack cancer cells.

GettingLibtayo (cemiplimab)in India

Libtayo (cemiplimab)has been approved in countries like the U.S. and Europe but is not yet available for commercial sale in India. However, it is accessible through the Named Patient Program (NPP) for eligible patients.

MitoGENE helps Indian patients accessLibtayo (cemiplimab)legally and safely under their doctor’s supervision. We handle the documentation, regulatory approvals, and logistics to ensure compliance with Indian regulations.

If you or your loved one may benefit from Libtayo (cemiplimab),MitoGENE is here to support your journey to access this treatment.

Disease Indications: Lung Cancer, Skin Cancer

Manufacturer: Sanofi

Medicine Approved by:

  • European Medical Agency (EMA)
  • Food and Drug Administration (FDA)
  • Health Canada
  • Pharmaceuticals and Medical Devices Agency (PMDA)

Usage:Intravenous

Available Dosage Form& Package

  • 1 vial of 350 mg/7 mL

Shipping:Cold Chain Shipping. Certain medicines can be affected by heat, light, or improper handling. Cold chain shipping uses temperature-controlled packaging and transport provided by specialized medical couriers to keep these medicines stable and effective. Due to the added care and equipment involved, this method is often more expensive than standard shipping.

What is Libtayo (cemiplimab)?

Libtayo is a PD-1 blocking antibody used to treat adults with:

  • Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) not eligible for curative surgery or radiation.
  • Advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI), or if an HHI is not appropriate.
  • Advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression (≥50% tumor proportion score), and no EGFR, ALK, or ROS1 mutations. Tumors must be metastatic or unresectable and unsuitable for chemoradiation.

How does Libtayo work?

Libtayo is a fully-human monoclonal antibody that targets the PD-1 receptor on immune cells. By blocking the PD-1/PD-L1 interaction, it reactivates T-cell activity and helps the immune system detect and destroy cancer cells. Many tumors upregulate PD-L1/PD-L2 to evade immune response—Libtayo interrupts this escape mechanism.

Approvals

Libtayo has been approved by several regulatory agencies:

  • FDA (USA):
    • Advanced CSCC (Sept 2018)
    • Advanced BCC (Feb 2021)
    • Advanced NSCLC (Feb 2021)
  • EMA (EU):
    • Advanced BCC (June 2019)
  • Health Canada:
    • Advanced BCC (April 2019)

It was the first FDA-approved treatment for advanced CSCC and received Priority Review and Breakthrough Therapy Designation for that indication.

Note: Additional regional approvals may apply. Contact our support team for specifics.

How is Libtayo taken?

  • Dose: 350 mg IV infusion over 30 minutes, every 3 weeks
  • Adjustments: May be needed based on side effects or clinical condition

Always consult your doctor for personalized treatment guidance.

Side Effects and Warnings

Serious immune-related adverse effects may include:

  • Pneumonitis
  • Colitis
  • Hepatitis
  • Endocrinopathies
  • Infusion reactions

Common side effects include:

  • Fatigue
  • Rash
  • Diarrhea

Special precautions:

  • Not recommended during pregnancy or breastfeeding (may be fatal to the fetus)
  • Not approved for pediatric use

Regular monitoring of liver, thyroid, and immune markers is advised during treatment. Refer to the official prescribing information for full safety guidance.

References

1. Summary of Product Characteristics [FDA]: Libtayo (cemiplimab) [PDF], Sanofi and Regeneron, March 2019 (revised).

2. Libtayo information for US Healthcare Professionals, Sanofi and Regeneron, accessed July 2019.

3. FDA news release: FDA approves first treatment for advanced form of the second most common skin cancer, FDA, accessed July 2019.

4. Summary of Product Characteristics [EMA]: Libtayo (cemiplimab) [PDF], Regeneron, October 2019 (revised).

5. Product Monograph [Health Canada]: Libtayo (cemiplimab) [PDF], Sanofi-Aventis, April 2019.

6. FDA approves LIBTAYO® (cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma
Regeneron press release, Feb 2021

7.FDA press release, Feb 2021

How to Access Libtayo (cemiplimab) in India in 4 Simple Steps with MitoGENE via the Named Patient Program (NPP)? If Libtayo (cemiplimab) is not yet approved or commercially available in India, MitoGENE can assist you in accessing it legally through the Named Patient Program (NPP). Here’s how the process works:

    Upload Prescription

    Upload Patient Consent Form

    Patient Consent Form
    Download

    Please download and complete this form, including your signature, and attach it to the request form or email it to info@mitogene.org along with the patient details.