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TALVEY

TALQUETAMAB

Manufacturer: Janssen Biotech, Inc.

Score: 144.0

Quick Summary

TALVEY is a bispecific GPRC5D-directed CD3 T-cell engager used for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. The drug has shown anti-tumor activity in mouse models of multiple myeloma and is administered via subcutaneous injection. Key clinical findings include response rate and durability of response, and important safety information includes warnings for cytokine release syndrome and neurologic toxicity. The main dosing recommendations involve a step-up dosing schedule and dose modifications for adverse reactions. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • TALVEY is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy
  • The drug has shown anti-tumor activity in mouse models of multiple myeloma
  • TALVEY is administered via subcutaneous injection

Important Safety Information

Warning

Cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome, can occur with TALVEY

Contraindications

Adverse Reactions

  • Cytokine release syndrome
  • Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome
  • Oral toxicity and weight loss
  • Infections
  • Cytopenias
  • Skin reactions
  • Hepatotoxicity

Dosing Recommendations

General Guidance

Dose modifications may be required for adverse reactions, including cytokine release syndrome, neurologic toxicity, and other adverse reactions

Relapsed or refractory multiple myeloma

Adult Dose

TALVEY 0.4 mg/kg weekly or 0.8 mg/kg every 2 weeks

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • TALVEY may cause fetal harm when administered to a pregnant woman
  • No available data on the use of TALVEY in pregnant women

Nursing Mothers

Pediatric Use

  • The safety and efficacy of TALVEY have not been established in pediatric patients

Geriatric Use

  • No overall differences in safety or effectiveness were observed in patients 65 to less than 74 years of age compared to younger patients
  • A higher rate of fatal adverse reactions was observed in patients 75 years of age or older compared to younger patients