FDA approves Sarclisa for patients with relapsed refractory multiple myeloma

Some eight weeks earlier than expected, the US Food and Drug Administration has approved Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

Sarclisa is expected to be available to patients in the USA shortly, said the drug’s developer, French pharma major Sanofi (Euronext: SAN) late Monday, noting that Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. It is the first cancer treatment wholly-owned by Sanofi to win approval in the past decade.

Sanofi, whose shares were up more than 2% at 87.36 euros mid-morning today, estimates the total third-line market opportunity in the USA and major European markets at $3.4 billion. The second-line market estimate is much larger, at $6 billion. Sanofi hopes to take a slice of the market dominated by Johnson & Johnson’s (NYSE: JNJ) Darzalex (daratumumab).