Pepaxti - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation.
melphalan flufenamide
Post-authorisation
On 14 September 2023, 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 a change to the existing indication for the treatment of adult patients with multiple myeloma. For information, the full indication for Pepaxti will be as follows1:
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-CD38 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 in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1New text in bold, removed text as strikethrough
CHMP post-authorisation summary of positive opinion for Pepaxti (II-02)
AdoptedReference Number: EMA/CHMP/405889/2023
English (EN) (124.95 KB - PDF)
First published: