Carvykti (ciltacabtagene autoleucel)
OrphanPRIMEATMPAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- ciltacabtagene autoleucel
- Company
- Janssen-Cilag International NV
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 24 Mar 2022
- EU approval
- Wed 25 May 2022
- Designations
- Orphan, PRIME, ATMP, Additional monitoring
- Application
- EMEA/H/C/005095
- ATC
- L01XL05
- Official record
- www.ema.europa.eu
Indication
Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.
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.