Pepaxti - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation
melphalan flufenamide
Post-authorisationHuman
On 17 September 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Pepaxti. The marketing authorisation holder for this medicinal product is Oncopeptides AB.
The CHMP adopted an extension to the existing indication as follows:
Pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three two prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti CD30 monoclonal antibody, lenalidomide and who have demonstrated disease progression on or after the last line of 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).
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.New text in bold, removed text as strikethrough.
Note: New text in bold, removed text as strikethrough.
CHMP post-authorisation summary of positive opinion for Pepaxti (VR-0000350278)
Adopted
Reference Number: EMADOC-1700519818-3429729
English (EN) (131.2 KB - PDF)
First published: