Paris, France (Press Release) – The U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for review the Biologics License Application (BLA) for isatuximab for the treat­ment of patients with re­lapsed / re­frac­tory multiple myeloma (RRMM). The target action date for the FDA de­ci­sion is April 30, 2020. Isatuximab is an inves­ti­ga­tional mono­clonal anti­body that targets a specific epitope on the CD38 re­cep­tor of a plasma cell.

The BLA is based on pos­i­tive results from ICARIA-MM, an open-label pivotal Phase 3 clin­i­cal trial of isatuximab in patients with RRMM. ICARIA-MM is the first pos­i­tive ran­dom­ized Phase 3 trial to eval­u­ate an anti­body in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone. Results from this trial were pre­sented at the 2019 American Society of Clinical Oncology Annual Meeting and the 2019 European Society of Hematology Annual Meeting.

Multiple myeloma is the second most common hema­to­logic malig­nan­cy¹, affecting more than 138,000² people world­wide. Multiple myeloma results in sig­nif­i­cant dis­ease burden. Patients with multiple myeloma con­tinue to relapse over time making it a dif­fi­cult to treat and incurable malig­nan­cy.

Isatuximab targets a specific epitope on the CD38 re­cep­tor. It is designed to trigger multiple, distinct mech­a­nisms of action that are believed to directly promote pro­grammed tumor cell death (apoptosis) and immuno­modu­la­tory activity.

Isatuximab re­ceived orphan desig­na­tion for re­lapsed / re­frac­tory multiple myeloma from both the FDA and the European Medicines Agency (EMA), and in the second quarter of 2019 the EMA ac­cepted for review the Marketing Authori­za­tion Application.

Isatuximab is cur­rently being eval­u­ated in multiple ongoing Phase 3 clin­i­cal trials in com­bi­na­tion with current standard treat­ments for people with re­lapsed / re­frac­tory or newly-diagnosed multiple myeloma. It is also under in­ves­ti­ga­tion for the treat­ment of other hema­to­logic malig­nan­cies and solid tumors. Isatuximab is an inves­ti­ga­tional agent and its safety and efficacy have not been fully eval­u­ated by any regu­la­tory authority.

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References

1. Kazandjian. Multiple myeloma epidemiology and survival: A unique malig­nan­cy. Semin Oncol. 2016;43(6):676-681. doi:10.1053/j/seminoncol.2016.11.004
2. Cowan AJ, Allen C, Barac A, et al. Global Burden of Multiple Myeloma: A Systematic Analysis for the Global Burden of Disease Study 2016. JAMA Oncol. 2018;4(9):1221–1227. doi:10.1001/jamaoncol.2018.2128

Source: Sanofi.