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Sanofi: FDA To Review Isatuximab As Potential Treatment For RRMM

French pharma major Sanofi (SNYNF,SNY) announced Wednesday that the U.S. Food and Drug Administration has accepted for review the Biologics License Application or BLA for isatuximab to treat patients with relapsed/refractory multiple myeloma or 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.

Sanofi said the BLA is based on positive results from ICARIA-MM, an open-label pivotal Phase 3 clinical trial of isatuximab in patients with RRMM.

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

The company noted that 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.

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