Initial US Approval:
2025
Key Clinical Studies:
Study AK105-304 (NCT04974398)
Drug Class/Description:
Programmed death receptor-1 (PD-1)-blocking antibody
Indications and Usage:
Penpulimab-kcqx is a programmed death receptor-1 (PD-1)-blocking antibody indicated:
- in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC)
- as a single agent for the treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
Dosage and Administration:
Penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine:
- 200 mg intravenously over 60 minutes every 3 weeks until disease progression or a maximum of 24 months.
Penpulimab-kcqx as a single agent:
- 200 mg intravenously over 60 minutes every 2 weeks until disease progression or a maximum of 24 months.
Dilute prior to administration.
Dosage Forms and Strengths:
Injection: 100 mg/10 mL (10 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 and hepatotoxicity, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, 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 penpulimab-kcqx based on severity and type of reaction.
- Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue penpulimab-kcqx based on the severity of the 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 to use effective contraception.
Adverse Reactions:
Penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine: The most common adverse reactions (≥20%) were nausea, vomiting, hypothyroidism, constipation, decreased appetite, decreased weight, cough, COVID-19 infection, fatigue, rash, and pyrexia.
Penpulimab-kcqx as a single agent: The most common adverse reactions (≥20%) were anemia and hypothyroidism.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted From:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761258s000lbl.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.
