Sanofi: FDA to Review Isatuximab for Relapsed/Refractory Multiple Myeloma

By Colin Kellaher

Sanofi S.A. (SAN.FR, SNY) Wednesday said the U.S. Food and Drug Administration accepted for review the company's biologics license application for isatuximab for patients with relapsed/refractory multiple myeloma.

The Paris drug maker said the agency set a target action date of April 30, 2020.

Multiple myeloma, a cancer that forms in a type of white blood cell called a plasma cell, affects more than 138,000 people worldwide. The disease causes cancer cells to accumulate in the bone marrow, where they crowd out healthy blood cells, according to the Mayo Clinic.

Sanofi said its FDA filing is based on results of a phase 3 trial in which isatuximab added to pomalidomide and dexamethasone showed a 40% reduction in the risk of disease progression or death for patients with relapsed/refractory multiple myeloma compared with pomalidomide and dexamethasone alone.

Sanofi said it is studying isatuximab in multiple phase 3 trials in combination with current standard treatments for people with relapsed/refractory or newly-diagnosed multiple myeloma.

The drug previously received orphan designation for relapsed/refractory multiple myeloma from the FDA and from the European Medicines Agency, which accepted Sanofi's marketing authorization application in the second quarter.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect less than 200,000 people in the U.S. and provides for a seven-year marketing exclusivity period against competition.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

July 10, 2019 06:50 ET (10:50 GMT)

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