Tecvayli (teclistamab)
- Region
- 🇪🇺 EU
- Active substance
- teclistamab
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 21 Jul 2022
- EU approval
- Tue 23 Aug 2022
- Designations
- PRIME, Additional monitoring
- Application
- EMEA/H/C/005865
- ATC
- L01FX24
- Official record
- www.ema.europa.eu
Indication
Tecvayli is indicated in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy 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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.