EC approval for Sarclisa for adults with relapsed and refractory multiple myeloma

The European Commission (EC) has approved Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.

Sarclisa, the first wholly-owned Sanofi (Euronext: SAN) cancer drug in a decade, is a monoclonal antibody (MAb) that binds to a specific epitope on the CD38 receptor of MM cells. It was approved by the US Food and Drug Administration in March this year, and is targeting a market currently led by Johnson & Johnson’s (NYSE: JNJ) Darzalex (daratumumab), which is licensed from Denmark’s Genmab (OMX: GEN).

Analysts have forecast peak sales of $1 billion annually for Sarclisa, but Darzalex, with first-quarter 2020 sales of $937 million, growing 49% year-on-year, looks set to achieve revenues in excess of $ billion this year. Moreover, the J&J drug has recently bagged FDA clearance of Darzalex Faspro, a subcutaneous formulation that offers much faster administration.