Initial US Approval:
2023
Key Clinical Studies:
POD1UM-303/InterAACT 2 (NCT04472429); POD1UM-202 (NCT03597295)
Drug Class/Description:
Programmed death receptor-1 (PD-1)-blocking antibody
Indications and Usage:
ZYNYZ is a programmed death receptor-1 (PD-1)–blocking antibody indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Dosage and Administration:
The recommended dosage of ZYNYZ is 500 mg as an intravenous infusion over 30 minutes every 4 weeks.
See full Prescribing Information for dosage modifications for adverse reactions and preparation and administration instructions.
Dosage Forms and Strengths:
Injection: 500 mg/20 mL (25 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 nephritis with renal dysfunction, and immune-mediated dermatologic adverse reactions, 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 ZYNYZ and administer corticosteroids based on the severity of reaction.
- Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue ZYNYZ based on severity of reaction.
- Complications of Allogeneic 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:
The most common (≥ 10%) adverse reactions are fatigue, musculoskeletal pain, pruritus, diarrhea, rash, pyrexia, and nausea.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted From:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761334Orig1s000correctedlbl.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.
