🇪🇺 Teclistamab Monotherapy in European Union

EMA authorised Teclistamab Monotherapy on 23 August 2022

Marketing authorisation

Application: EMEA/H/C/005865
Marketing authorisation holder: Janssen-Cilag International N.V.
Local brand name: Tecvayli
Indication: TECVAYLI is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Pathway: conditional, PRIME
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Teclistamab Monotherapy approved in European Union?

Yes. EMA authorised it on 23 August 2022.

Who is the marketing authorisation holder for Teclistamab Monotherapy in European Union?

Janssen-Cilag International N.V. holds the EU marketing authorisation.