Talvey (talquetamab)
PRIMEConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- talquetamab
- Company
- Janssen-Cilag International N.V.
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 20 Jul 2023
- EU approval
- Mon 21 Aug 2023
- Designations
- PRIME, Conditional, Additional monitoring
- Application
- EMEA/H/C/005864
- ATC
- L01FX29
- Official record
- www.ema.europa.eu
Indication
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.
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.