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FDA Approvals, News & UpdatesMultiple Myeloma

Sarclisa Now Approved for Relapsed or Refractory Multiple Myeloma

In March 2021, the FDA approved a new indication for Sarclisa (isatuximab-irfc), in combination with Kyprolis and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma.
June 2021 Vol 7 No 3

In March 2021, the FDA accelerated the approval of a new indication for Sarclisa (isatuximab-irfc; from sanofi-aventis), a CD38-directed antibody, in combination with Kyprolis and dexamethasone, for the treatment of adults with relapsed (coming back) or refractory multiple myeloma who have received 1 to 3 previous therapies.

Sarclisa was initially approved by the FDA in 2020, in combination with Pomalyst and dexamethasone, for adults with relapsed or refractory multiple myeloma who have received 2 or more therapies, including Revlimid and a proteasome inhibitor (such as Velcade).

The FDA approval of Sarclisa plus Kyprolis and dexamethasone was based on a multicenter, multinational, randomized, open-label, 2-arm, phase 3 clinical trial of patients with relapsed or refractory multiple myeloma who had previously received 1 to 3 lines of therapy. The study included 302 patients who were assigned to receive either Sarclisa plus Kyprolis and dexamethasone or Kyprolis and dexamethasone alone.

The time of survival without disease progression was not reached (meaning patients are still responding to therapy) in those who received Sarclisa plus Kyprolis and dexamethasone versus 20 months in patients who received Kyprolis and dexamethasone alone. This amounts to a 45% risk reduction of disease progression or death with the addition of Sarclisa to the treatment regimen.

The most common side effects with Sarclisa plus Kyprolis and dexamethasone were upper respiratory tract infection, infusion-related reactions, fatigue, hypertension, diarrhea, pneumonia, dyspnea, insomnia, bronchitis, cough, and back pain.

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Last modified: July 22, 2021

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