Abecma (idecabtagene vicleucel)
OrphanPRIMEATMPAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- idecabtagene vicleucel
- Company
- Bristol-Myers Squibb Pharma EEIG
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 24 Jun 2021
- EU approval
- Wed 18 Aug 2021
- Designations
- Orphan, PRIME, ATMP, Additional monitoring
- Application
- EMEA/H/C/004662
- ATC
- L01
- Official record
- www.ema.europa.eu
Indication
Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two 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.