The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Sarclisa (isatuximab).
The committee has released the recommendation for the Sanofi drug in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of certain adult patients with relapsed and refractory multiple myeloma.
Sanofi says the indication is for those who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.
Following the decision, the European Commission (EC) will review the CHMP recommendation and a final decision on the Marketing Authorisation Application for Sarclisa in the EU is expected in the coming months.
The CHMP positive opinion is based on data from ICARIA-MM, in which Sarclisa added to pom-dex demonstrated a statistically significant improvement of progression free survival (PFS) with a median PFS of 11.53 months compared to 6.47 months with pom-dex alone.
Despite available treatments, multiple myeloma remains an incurable malignancy, and is associated with significant patient burden. Since multiple myeloma does not have a cure, most patients will relapse.
“Relapsed and refractory multiple myeloma is a complicated disease that continuously develops resistance to treatment, creating a significant need for continued innovation,” said John Reed, Sanofi’s global head of research & development. “This positive CHMP opinion for Sarclisa brings us closer to our ambition to deliver a new treatment option for patients in Europe with relapsed and refractory multiple myeloma.”
Multiple myeloma is the second most common hematologic malignancy1, with more than 138,000 new diagnoses of multiple myeloma worldwide yearly. In Europe, approximately 39,000 patients are diagnosed with multiple myeloma each year.