Lynozyfic (linvoseltamab)
ConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- linvoseltamab
- Company
- Regeneron Ireland Designated Activity Company (DAC)
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 27 Feb 2025
- EU approval
- Wed 23 Apr 2025
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/006370
- ATC
- L01FX
- Official record
- www.ema.europa.eu
Indication
Monotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal 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.