# Talquetamab

Talquetamab (Talvey, Janssen-Cilag International N.V.) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Multiple myeloma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 3rd line+ | After at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and demonstrated disease progression on the last therapy |

## Products

### Talvey

- Company: Janssen-Cilag International N.V.
- Target: GPRC5D × CD3 bispecific antibody
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX29
- EU approval: 21 Aug 2023
- Label revised: 28 Nov 2025
- Status: conditional approval, orphan medicine, PRIME
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/talvey-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/talvey-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/talvey

Mechanism (SmPC section 5.1): Binds GPRC5D and CD3 to recruit T cells to GPRC5D-expressing cells, triggering T-cell activation and perforin- and granzyme-mediated lysis.

## Label wording

- **Talquetamab** (Talvey), Multiple myeloma, 3rd line+: “TALVEY is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/talvey-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/talquetamab