FDA Approves New Therapy for Patients with Previously Treated Multiple Myeloma | FDA

FDA Approves New Therapy for Patients with Previously Treated Multiple Myeloma | FDA

FDA Approves New Therapy for Patients with Previously Treated Multiple Myeloma

Today, the U.S. Food and Drug Administration approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa, administered through intravenous (IV) infusion, is a CD38-directed cytolytic antibody that works by helping certain cells in the immune system attack multiple myeloma cancer cells. Common side effects for patients taking Sarclisa were neutropenia (abnormally low levels of white blood cells), infusion-related reactions, pneumonia (infection of the air sacs in one or both of the lungs), upper respiratory tract infection, diarrhea, anemia, lymphopenia (decrease in the level of white blood cells) and thrombocytopenia (abnormally low levels of platelets). Sarclisa can cause serious side effects, which include the following. Sarclisa can cause IV infusion-related reactions. In a grade three or higher (severe) reaction, the Sarclisa infusion should be permanently discontinued and health care professionals should institute appropriate medical management. Sarclisa can also cause neutropenia and health care professionals should monitor a patient’s complete blood cell count periodically during treatment, as well as monitor patients with neutropenia for signs of infection. Higher incidences of second primary malignancies (a second primary cancer that may occur in the same tissue or organ as the first cancer or in another region of the body) were observed in a controlled clinical trial of patients with multiple myeloma receiving Sarclisa. Therefore, health care professionals should monitor patients for the development of a second primary malignancy when taking Sarclisa. Laboratory test interference may be experienced with Sarclisa. Blood banks should be informed that patients are receiving Sarclisa because the drug may interfere with certain tests that are done by blood banks (such as antibody screening) for patients who need a blood transfusion. Health care professionals should type and screen patients prior to starting treatment with Sarclisa. Sarclisa may interfere with the assays (tests) used to monitor M-protein, which may impact the determination of complete response. Health care professionals should advise pregnant women that Sarclisa may cause harm to a developing fetus. Women who are pregnant should not use Sarclisa. Women planning to become pregnant should use effective contraceptives during and for at least five months after treatment.

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