Anike

In combination with a platinum agent plus gemcitabine for the first-line treatment of patients with recurrent or metastatic nonkeratinizing nasopharyngeal carcinoma.

200 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months.

Injection: 200 mg/10 mL (20 mg/mL) single-dose vial

None listed in the prescribing information.

• Immune-Mediated Adverse Reactions: Including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and dermatologic reactions.
• Infusion-Related Reactions: Interrupt or slow infusion for Grade 1-2; permanently discontinue for Grade 3-4.
• Embryo-Fetal Toxicity: Can cause fetal harm.

Nausea (45%), Anemia (38%), Fatigue (32%), Decreased Appetite (28%), Neutropenia (26%), Vomiting (22%), Rash (18%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Corticosteroids: Avoid systemic corticosteroids before starting penpulimab.
Immunosuppressants: May reduce efficacy.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Penpulimab is a humanized IgG1 monoclonal antibody that blocks the PD-1/PD-L1 interaction, releasing PD-1-mediated inhibition of immune responses including anti-tumor immunity.

Steady state ~12 weeks Q3W. Half-life: ~25 days. Volume of distribution: ~5.6 L.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• JUPITER-02 — Penpulimab + chemo vs placebo + chemo in NPC. Phase III, n=289.
  🔬 NCT03581786 ↗ 📄 Primary Publication ↗

Anike has FDA-approved indications across the following cancer types covered on CancerDrugEvidence: