EMA — authorised 23 April 2025
- Application: EMEA/H/C/006370
- Marketing authorisation holder: Regeneron Ireland Designated Activity Company (DAC)
- Local brand name: Lynozyfic
- 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.
- Pathway: conditional
- Status: approved
The European Medicines Agency (EMA) granted conditional marketing authorisation for Lynozyfic on 23 April 2025. Lynozyfic is indicated 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. This approval was granted under the conditional approval pathway.