Pepaxti

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melphalan flufenamide

Authorised
This medicine is authorised for use in the European Union.

Overview

Pepaxti is a medicine used to treat adults with multiple myeloma (a cancer of the bone marrow) when the cancer has not responded to previous treatments (refractory).

It is used in combination with dexamethasone (an anti-inflammatory medicine) in adults who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti‑CD38 antibody, and whose disease has worsened since the last treatment.

For patients who have had an autologous stem cell transplantation (a procedure where the patient’s bone marrow is cleared of cells and replaced by stem cells from the patients themselves), Pepaxti can be used if the time from transplantation to when the cancer comes back is at least three years.

Multiple myeloma is rare, and Pepaxti was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 March 2015. Further information on the orphan designation can be found here: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-15-1463

Pepaxti contains the active substance melphalan flufenamide.

This EPAR was last updated on 06/09/2022

Authorisation details

Product details
Name
Pepaxti
Agency product number
EMEA/H/C/005681
Active substance
Melphalan flufenamide hydrochloride
International non-proprietary name (INN) or common name
melphalan flufenamide
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L01AA10
Publication details
Marketing-authorisation holder
Oncopeptides AB
Date of issue of marketing authorisation valid throughout the European Union
17/08/2022
Contact address

Vastra Tradgardsgatan 15
111 53 Stockholm
Sweden

Product information

23/06/2022 Pepaxti - EMEA/H/C/005681 -

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic 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).

Assessment history

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