Second indication of Sarclisa for relapsed MM approved by EC

19 April 2021

The European Commission (EC) has approved Sarclisa (isatuximab) in combination with Amgen's (Nasdaq: AMGN) Kyprolis (carfilzomib) and dexamethasone (Kd) for the treatment of adult patients with relapsed multiple myeloma (MM) who have received at least one prior therapy.

This marks the second EC approval for French pharma major Sanofi’s (Euronext: SAN) Sarclisa in combination with a standard of care regimen in less than 12 months. Sanofi shares were up 1.1% at 85.97 euros by late morning trading today.

This adds to the competition against Johnson & Johnson (NYSE: JNJ) unit Janssen’s multiple myeloma drug Darzalex (daratumumab), which Sanofi hopes Sarclisa will outperform. Janssen has also been able to secure approval for a new subcutaneous formulation of Darzalex, dubbed Darzalex Faspro, offering a much faster and easier mode of administration.

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