EC Grants Marketing Authorization for Melphalan Flufenamide Plus Dexamethasone in Myeloma

By Cecilia Brown - Last Updated: November 16, 2022

The European Commission (EC) has granted marketing authorization for melphalan flufenamide in combination with dexamethasone for adults with MM.

Advertisement

The drug’s use under the authorization is limited to adults with MM who have received at least three prior therapies; whose disease is refractory to at least one immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody; and who have demonstrated disease progression during or after their most recent line of therapy.

The authorization stipulates that patients who had a prior autologous hematopoietic stem cell transplant (AHSCT) should have a time to progression of at least three years after transplant.

Melphalan flufenamide is a lipophilic peptide conjugated alkylating drug that selectively delivers cytotoxic agents into tumor cells, inhibiting proliferation and inducing apoptosis.

The marketing authorization is valid in all European Union states, as well as Iceland, Lichtenstein, and Norway. The manufacturer of melphalan flufenamide plans to submit a type II variation at the end of the year for earlier lines of treatment in patients with relapsed/refractory MM.

The marketing authorization is based on data on the doublet treatment from the phase II HORIZON study and is supported by data from the randomized, controlled, phase III OCEAN study. The HORIZON study evaluated melphalan flufenamide in combination with dexamethasone in 157 heavily pretreated patients with MM, many of whom were triple-class refractory and received at least four prior lines of treatment. The overall response rate (ORR) was 28.8% in patients with MM who were triple-class refractory and did not have AHSCT or those who progressed after more than 36 months post-AHSCT.

Source: PR Newswire, August 2022

Advertisement
Advertisement
Advertisement