Pepaxti (melphalan flufenamide)
- Region
- 🇪🇺 EU
- Active substance
- melphalan flufenamide
- Company
- Oncopeptides AB (publ)
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- EU approval
- Wed 17 Aug 2022
- Application
- EMEA/H/C/005681
- ATC
- L01AA10
- Official record
- www.ema.europa.eu
Indication
Pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.4).
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.