FDA Approves Darzalex Faspro Regimen for Some With Multiple Myeloma

Darzalex Faspro plus Velcade, Revlimid and dexamethasone is a new treatment for some patients with multiple myeloma.

The Food and Drug Administration (FDA) has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) with Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone (a regimen called Darzalex Faspro-VRd) for induction and consolidation in patients with multiple myeloma.

Of note, patients eligible for this treatment regimen are newly diagnosed with multiple myeloma and are eligible for an autologous stem cell transplant, according to the alert from the FDA. An autologous stem cell transplant is when healthy stem cells are taken from the patient before treatment and injected back into their bone marrow after treatment, as the National Cancer Institute defines.

This approval of Darzalex Faspro is based on the phase 3 PERSEUS trial, which included 709 patients aged 70 and younger. Patients were randomly assigned into two treatment groups: 355 patients were treated with Darzalex Faspro-VRd and 354 patients received only Velcade, Revlimid and dexamethasone (VRd).

The main outcome measured in the trial was progression-free survival (PFS; time patients live without their disease worsening or spreading). Patients in the Darzalex Faspro-VRd group demonstrated improved PFS when compared with the VRd group.

Importantly, the median PFS was not reached in either group, meaning not enough patients experienced disease progression or spreading for the researcher to calculate an average time to progression or death. However, patients who were treated with Darzalex Faspro-VRd showed a reduction in the risk of experiencing disease progression or death by 60% versus treatment of VRd alone.

In terms of side effects, the most common ones that occurred in approximately 20% or more included peripheral neuropathy (weakness, numbness and pain in the hands and feet), fatigue, edema (fluid that causes swelling in the extremities), fever, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia and rash.

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