Initial US Approval:
2018
Key Clinical Studies:
C-POST (NCT03969004)
Drug Class/Description:
Programmed death receptor-1 (PD-1) blocking antibody
Indications and Usage:
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.
- or 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.
Non-Small Cell Lung Cancer (NSCLC)
- in combination with platinum‐based chemotherapy for the first‐line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is:
- locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or
- metastatic.
- as single agent for the first-line treatment of adult patients with NSCLC 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, and is:
- locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or
- metastatic.
Dosage and Administration:
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.
Dosage Forms and Strengths:
Injection: 350 mg/7 mL (50 mg/mL) solution in a single-dose vial.
Contraindications:
None.
Warnings and Precautions:
- 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, immunemediated 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.
- Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT): Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.
- Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.
Adverse Reactions:
Most common adverse reactions (≥15%):
LIBTAYO as a single agent in mCSCC or laCSCC, mBCC 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.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted From:
https://www.regeneron.com/downloads/libtayo_fpi.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
