FDA approves Sarclisa with Kyprolis for multiple myeloma

The US Food and Drug Administration has approved French pharma major Sanofi’s (Euronext: SAN) Sarclisa (isatuximab-irfc), in combination with Amgen's (Nasdaq: AMGN) Kyprolis (carfilzomib) and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy.

This marks the second FDA approval for Sarclisa, which is also cleared in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

The FDA approved this application three months ahead of the FDA goal date, the agency noted.