BioCentury
ARTICLE | Regulation

Sanofi sees first fruit of renewed oncology commitment with Sarclisa approval

Sanofi solidifies comeback with first FDA cancer approval in more than a decade

March 3, 2020 12:09 AM UTC
Updated on Mar 6, 2020 at 9:46 PM UTC

Sarclisa isatuximab will be the first oncology drug Sanofi launches in more than a decade, its approval Monday marking the pharma’s first cancer win after its re-entry into the space. The company’s next step is finding a home for the anti-CD38 mAb in a crowded multiple myeloma market.

FDA approved the Sanofi (Euronext:SAN; NASDAQ:SNY) drug in combination with pomalidomide and dexamethasone (pom-dex) to treat relapsed refractory multiple myeloma in patients who have received at least two prior therapies, including Revlimid lenalidomide and a proteasome inhibitor. The approval comes almost two months before its April 30 PDUFA...