FDA approves Sarclisa for multiple myeloma.- Sanofi

The FDA has approved Sarclisa (isatuximab-irfc), from Sanofi, 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 offers an intravenous (IV) administration and is dosed at 10 mg/kg, in combination with pom-dex, every week for four weeks and then every two weeks, until disease progression or unacceptable toxicity. The first cycle is administered in an infusion time of 200 minutes, which can decrease to 75 minutes for the third cycle onwards. A treatment cycle is 28 days. In the ICARIA-MM study, Sarclisa added to pom-dex (Sarclisa combination therapy) demonstrated a statistically significant improvement in progression free survival (PFS) with a median PFS of 11.53 months compared to 6.47 months with pom-dex alone (HR 0.596, 95% CI: 0.44-0.81, p=0.0010). Sarclisa combination therapy also demonstrated a significantly greater overall response rate compared to pom-dex alone (60.4% vs. 35.3%, p<0.0001). the most common adverse reactions occurring in 20 or more of patients in patients who received sarclisa combination therapy were neutropenia 96 infusion-related reactions 39 pneumonia 31 upper respiratory tract infection 57 and diarrhea 26. serious adverse reactions that occurred in more than 5 of patients who received sarclisa combination therapy included pneumonia 25.3 and febrile neutropenia 12.3. permanent discontinuation of sarclisa combination therapy due to an adverse reaction grades 3-4 occurred in 7 of patients and 3 of patients discontinued due to an infusion-related reaction.>