A bid from France’s Sanofi (Euronext: SAN) to market the anti-CD38 therapy isatuximab will be reviewed by the US regulator, with a decision expected by April 30, 2020.
The application is based on positive results from ICARIA-MM study, an open-label Phase III trial which tested a combination of isatuximab, pomalidomide and dexamethasone in relapsed/refractory multiple myeloma (RRMM).
The firm’s results show the combination prolonged progression free survival (PFS) by five months compared to standard of care - Celgene’s (Nasdaq: CELG) Pomalyst/Imnovid (pomalidomide) together with the corticosteroid dexamethasone.
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