Sanofi: request for review of isatuximab accepted

(CercleFinance.com) - The US FDA has accepted to review the Biologics License Application (BLA) for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) says Sanofi.

It is set to issue a decision on 30 April 2020.

The BLA is based on the positive results from the ICARIA-MM, the first positive randomised Phase 3 trial to evaluate an antibody in combination with pomalidomide and dexamethasone. These results were presented this year at annual congresses.

Multiple myeloma is the second most common hematologic cancer in terms of frequency, affecting more than 138,000 people all over the world. It is difficult to treat because patients are prone to relapse and often, it is incurable.

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