FDA Approves New Therapy for Patients with Previously Treate
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U.S. Food and Drug Administration has 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. The FDA has granted approval of Sarclisa to Sanofi-Aventis U.S. LLC.

Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, produce an abnormal protein and push out other healthy blood cells from the bone marrow resulting in a weakened immune system and other bone or kidney problems.

The approval was based on the results of a clinical trial that involved 307 patients with relapsed and refractory myeloma who had at least 2 previous therapies, including lenalidomide and a proteasome inhibitor. The participants were broken up into 2 groups: 1 was given isatuximab-irfc plus pomalidomide and low-dose dexamethasone, while the other group was given just pomalidomide and low-dose dexamethasone.
Patients on the isatuximab-irfc arm had a 40% reduction in the risk of disease progression or death compared to the patients who did not receive the agent. The overall response rate was 60.4% and 35.5% in the 3-drug and 2-drug arms, respectively.

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). Therefore, health care professionals should monitor patients for the development of a second primary malignancy when taking Sarclisa.

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-patients-previously-treated-multiple-myeloma
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Dr. S●●●●●m S●●●●y P●●●●●l
Dr. S●●●●●m S●●●●y P●●●●●l General Medicine
Thank you for info PlexusMd.
Mar 4, 2020Like