Madrid, Spain (Press Release) – PharmaMar (MSE: PHM) has announced today that the European Med­i­cines Agency (EMA) has accepted to assess the Marketing Authorization Application (MAA) for Aplidin® (pliti­depsin) in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of re­lapsed / refractory multiple myeloma (MM).

PharmaMar submitted the above mentioned appli­ca­tion for the antitumor drug of marine origin, Aplidin®, in com­bi­na­tion with dexa­meth­a­sone given the positive results obtained from the ADMYRE study. Plitidepsin could be a thera­peutic alter­na­tive for patients suffering from re­lapsed and/or refractory multiple myeloma.

After this acceptance, the EMA is going to start the assess­ment of this poten­tial treat­ment for a type of blood cancer which accounts for 10% of all hema­to­logical malig­nan­cies.

The ADMYRE clin­i­cal trial is a ran­domized, Phase III study where the efficacy and safety of Aplidin® with dexa­meth­a­sone versus dexa­meth­a­sone alone in patients with re­lapsed / refractory MM after at least three, but no more than six, prior thera­peutic regi­mens has been eval­u­ated. The results of the ADMYRE study showed a statistically sig­nif­i­cant 35% reduction in the risk of pro­gres­sion or death over the comparator. The study met its pri­mary end­point.

About multiple myeloma

Multiple myeloma is a relatively uncommon type of blood cancer, which accounts for 10% of all hemato­logical malig­nan­cies, this being caused by malignant plasma cells that very rapidly multiply^[i]. Normal plasma cells are white blood cells, which form part of the immune system, found in the bone marrow that produce the anti­bodies nec­es­sary for fighting in­fec­tions^[ii]. Abnormal cells produce a type of anti­body that does not benefit the body and accumulate, thus preventing normal cells from functioning properly. In 2015, 26,850 new cases were diag­nosed in the US, and about 11,200 people died from this disease[iii].In Europe, the incidence is 4.5-6.0 out of 100 000 diag­nosed per year^[iv], and the prev­a­lence is 18 cases per 100 000 diag­nosed over five years^[v].

References:

1. http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma
2. http://www.myeloma.org.uk/information/what-is-myeloma/
3. http://seer.cancer.gov/statfacts/html/mulmy.html
4. http://www.esmo.org/Guidelines/Haematological-Malignancies/Multiple-Myeloma
5. GLOBOCAN 2012, IARC - 6.9.2016

Source: PharmaMar.