Cemiplimab (Libtayo)

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General information

Class/mechanism: PD-1 antibody. Cemiplimab is a recombinant human monoclonal antibody which binds to the PD-1 receptor on T-cells and blocks its interaction with PD-L1 and PD-L2, which immune system inhibition and facilitates anti-tumor immune response.[1][2][3]
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Toxicity management

Diseases for which it is used

Patient drug information

History of changes in FDA indication

Cutaneous basal cell carcinoma

  • 2/9/2021: Approved for patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate. (New disease entity; based on R2810-ONC-1620)
  • 2/9/2021: Accelerated approval for patients with metastatic BCC (mBCC) previously treated with a HHI or for whom a HHI is not appropriate. (New disease entity; based on R2810-ONC-1620)

Cutaneous squamous cell carcinoma

  • 9/28/2018: FDA approved for patients with metastatic cutaneous squamous cell carcinoma (CSCC). (Based on R2810-ONC-1423 and R2810-ONC-1540)
  • 9/28/2018: FDA approved for patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation. (Based on R2810-ONC-1423 and R2810-ONC-1540)

Non-small cell lung cancer

  • 2/22/2021: for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] > 50%) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations. (New disease entity; based on EMPOWER-Lung 1)

History of changes in EMA indication

  • 6/28/2019: Initial marketing authorization as Libtayo.

Also known as

  • Code name: REGN2810
  • Generic name: cemiplimab-rwlc
  • Brand name: Libtayo