Talvey

talquetamab · Janssen-Cilag International N.V.
ORPHAN PRIME CONDITIONAL APPROVAL AUTHORISED IN THE EU

What Talvey is used for

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.

Approved use, as published by the European Medicines Agency.

What the labels mean

  • Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
  • PRIME: a priority medicine that the EMA supported early because it may meet an unmet need.
  • Conditional approval: approved on less complete data because the need is high; more data must follow.

Key facts

Brand
Talvey
Active substance
talquetamab
Disease area
Multiple Myeloma
Medicine group
Antineoplastic agents
ATC code
L01FX29
Marketing authorisation holder
Janssen-Cilag International N.V.
Authorised in the EU since
2023

Official information

In the USA

Same active substance: Talvey

Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.

Common questions

What is Talvey used for?

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.

What is the active substance in Talvey?

Talvey contains talquetamab.

Who makes Talvey?

The EU marketing authorisation holder is Janssen-Cilag International N.V..

Is Talvey an orphan medicine?

Yes. Talvey is designated an orphan medicine in the EU, for a rare disease (Multiple Myeloma).

Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.

← All specialty medicines, EU

For information only, not medical advice. This page is a plain-language summary written from standard prescribing information and the public guides linked below. Brands sometimes change their formula, so always check the composition printed on the pack. Doses here are typical adult doses; yours may differ. Do not start, stop or change a medicine without your doctor or pharmacist, and keep all medicines away from children. In an emergency, call 112 (India) or your local emergency number.