Sanofi : FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma
July 10 2019 - 1:00AM
FDA to review isatuximab as a potential treatment for
relapsed/refractory multiple myeloma
PARIS – July 10, 2019 - 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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Media Relations Contact Ashleigh Koss Tel.: +1
908-981-8745 Ashleigh.Koss@sanofi.com |
Investor
Relations Contact George Grofik Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com |
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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
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