FDA Approves Sarclisa In Newly Diagnosed Transplant-Ineligible Multiple Myeloma

The Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) with Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone, a combination known as Isa-VRd, for the treatment of adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT, when a patient’s own stem cells are collected, stored and infused back into them after treatment).

The efficacy of Sarclisa, the FDA announced, was determined in the IMROX phase 3 trial, which enrolled 446 patients to receive the Velcade, Revlimid and dexamethasone with or without Sarclisa.

In the trial, the Sarclisa regimen demonstrated a 40% reduction in the risk of disease progression or death. The median progression-free survival (PFS, the time a patient lives without their disease spreading or worsening) was not reached in the Isa-VRd arm, meaning fewer than half of the patients in that arm had experienced disease progression, and 54.3 months in the Sarclisa-free arm.

The most common side effects experienced by at least 20% of participants, the agency reported, were upper respiratory tract infection, diarrhea, fatigue, peripheral sensory neuropathy, pneumonia, musculoskeletal pain, cataract, constipation, peripheral edema, rash, infusion-related reaction, insomnia and COVID-19 infection.

Sarclisa was approved by the FDA in 2020 in combination with pomalidomide and dexamethasone for adults with multiple myeloma who received at least two prior therapies including lenalidomide and a proteasome inhibitor. In 2021, it was approved by the agency in combination with Kyprolis (carfilzomib) and dexamethasone to treat adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

According to the National Cancer Institute, Sarclisa is a monoclonal antibody that binds to the protein CD38 found on some immune and cancer cells, including myeloma cells, and may block CD38 and help the immune system kill cancer cells.

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