Pepaxti
What Pepaxti is used for
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).
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Pepaxti
- Active substance
- melphalan flufenamide
- Disease area
- Multiple Myeloma
- Medicine group
- Antineoplastic agents
- ATC code
- L01AA10
- Marketing authorisation holder
- Oncopeptides AB (publ)
- Authorised in the EU since
- 2022
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Pepaxti used for?
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).
What is the active substance in Pepaxti?
Pepaxti contains melphalan flufenamide.
Who makes Pepaxti?
The EU marketing authorisation holder is Oncopeptides AB (publ).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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