TALVEY talquetamab

Drug Class

Bispecific GPRC5D-directed CD3 T-cell engager

Mechanism

Binds GPRC5D on myeloma cells and CD3 on T-cells, directing T-cell-mediated cytotoxicity against GPRC5D-positive myeloma cells.

Approved Indication

Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

What This Means For Patients

Talvey (talquetamab) is a bispecific antibody indicated for patients with advanced relapsed or refractory multiple myeloma. It bridges tumor GPRC5D antigens and T-cells, enabling targeted immune destruction of cancer cells. It is clinically accessible in Boao Lecheng under Hainan's special-import policy.

Regulatory Approvals

• FDA — approved (2023) — label
• EMA — approved (2023) — source

Pivotal Clinical Evidence

• MonumenTAL-1 — Chari et al., N Engl J Med 2022 (NCT03399799) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761337s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/talvey