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  • Libtayo

Libtayo (cemiplimab)

Details

pCPA file number

22889

Manufacturer:

Regeneron

Status:

Concluded with an LOI

Indication:

Non-small cell lung cancer (NSCLC) expressing PD-L1 in ? 50% of tumour cells (Tumour Proportion Score [TPS] ? 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, first-line treatment of adult patients who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC

Negotiation Timeline

  • Initiation

    A drug is identified and brought into a pCPA process (see standard negotiation process or expedited negotiation pathways).

  • Consideration

    The pCPA considers the evidence (including HTA reimbursement recommendations) and gathers other data to inform the negotiation approach, in alignment with the needs of public drug plans. This phase concludes when the pCPA sends a letter of engagement to the manufacturer. 

    Letter of engagement sent to manufacturer

    August 30, 2024

    This lets the manufacturer know the pCPA is ready to start negotiating.

  • Negotiation

    The pCPA negotiation team reaches out to the manufacturer to outline next steps, then we exchange offers to try to reach an agreement on terms and funding conditions.

  • Completion

    The pCPA creates a letter of intent outlining negotiated terms. If the negotiation ended without an agreement, the pCPA sends a letter letting the manufacturer know that the negotiation is closed. 

    Negotiation process concluded

    March 3, 2025

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Libtayo (cemiplimab)

Status:

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Manufacturer:

Sanofi-Aventis Canada Inc.

Indication:

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Last updated:

November 4, 2020

Libtayo (cemiplimab)

Status:

Concluded without agreement

Manufacturer:

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Indication:

For the treatment of patients with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor

Last updated:

July 28, 2023

Libtayo (cemiplimab)

Status:

Concluded without agreement

Manufacturer:

Sanofi-Aventis Canada Inc.

Indication:

Non-small cell lung cancer (NSCLC) expressing PD-L1 in ? 50% of tumour cells (Tumour Proportion Score [TPS] ? 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, first-line treatment of adult patients who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC

Last updated:

July 28, 2023

Libtayo (cemiplimab)

Status:

Concluded with an LOI

Manufacturer:

Regeneron

Indication:

in combination with platinum-based chemotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) whose tumors have no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or c-ROS oncogene 1 (ROS1) aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC

Last updated:

March 3, 2025

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Page updated: February 4, 2026

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