New Sanofi Sarclisa treatment for multiple myeloma approved by FDA
pharmafile | April 1, 2021 | News story | | FDA, FDA Approval, Sanofi, Sarclisa, multiple myeloma
Sanofi’s Sarclisa drug has been approved by the FDA in combination with carfilzomib and dexamethasone (Kd) for the treatment of relapsed or refractory multiple myeloma (rrMM) for adult patients who have already received at least one prior line of therapy.
The decision follows the Phase III IKEMA trial, which featured 302 patients with relapsed multiple myeloma across 69 centers spanning 16 countries. The study found that Sarclisa added to Kd reduced the risk of disease progression or death by 45%, versus Kd alone.
This marks the second FDA approval for Sarclisa, which is also approved in combination with pomalidomide and dexamethasone for the treatment of adults with rrMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Multiple myeloma (MM) is the second most common haematologic malignancy, with around 160,000 diagnoses worldwide every year.
Despite available treatments, MM remains an incurable malignancy, meaning most patients will relapse. Relapsed MM is the term for when the cancer returns after treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy.
Dr Thomas G Martin, Associate Director of the Myeloma Program at The University of California, said: ”This approval is an important advancement for patients whose disease has relapsed and reinforces the potential for Sarclisa to become a standard of care in relapsed or refractory multiple myeloma.”
Dr Peter C Adamson, Global Development Head of Oncology and Pediatric Innovation at Sanofi, added: ”Treatment of patients with relapsed or refractory multiple myeloma remains challenging and the prognosis for patients experiencing multiple relapses unfortunately is poor.
“With this approval, Sarclisa is now included in two standard of care regimens for the treatment of patients with multiple myeloma as early as first relapse. Today’s milestone further supports our ambition for Sarclisa to become the anti-CD38 of choice for patients with relapsed or refractory multiple myeloma.”
Jack Goddard
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