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Sarclisa (isatuximab)

Region

🇪🇺 EU

Active substance

isatuximab

Company

Sanofi Winthrop Industrie

Status

Authorised

Therapeutic area

Multiple Myeloma

CHMP opinion

Thu 26 Mar 2020

EU approval

Sat 30 May 2020

Application

EMEA/H/C/004977

ATC

L01XC38

Official record

www.ema.europa.eu

Indication

Sarclisa is indicated:  In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. In combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. In combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇺🇸 Sarclisa Escena Approved · Sanofi-Aventis U.S. Llc

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.