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Sanofi’s Sarclisa Gets EMA Backing In Myeloma, Mirroring FDA OK

But Experts Doubt It Can Overtake J&J’s Entrenched Darzalex

 
• By Sten Stovall

The EMA has recommended Sanofi’s anti-CD38 antibody Sarclisa as a combination-based third-line treatment for multiple myeloma, after US approval earlier in March.

Silver medal
Sarclisa is second anti-CD38 to reach market after Darzalex • Source: Shutterstock

The European Medicines Agency has recommended Sanofi’s anti-CD38 antibody Sarclisa as a combination-based third-line treatment for multiple myeloma, mirroring an FDA OK earlier in March, but analysts said the drug’s overall commercial prospects look limited when viewed against those of Johnson & Johnson’s entrenched Darzalex, which generated $3bn globally in 2019.

Sarclisa (isatuximab) was approved by the US Food and Drug Administration (FDA) on 2 March in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed refractory multiple myeloma who have received at least two other treatments, including Bristol-Myers Squibb Co.'s Revlimid (lenalidomide) and a proteasome inhibitor

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