Sarclisa was recently approved for the treatment of multiple myeloma when taken with pomalidomide and dexamethasone. The FDA indicated that this treatment is for those who have been treated with two prior therapies. This approval came after a trial of Sarclisa showed positive results.
About Multiple Myeloma
Multiple myeloma is a form of cancer that causes malignant cells to accumulate in the bone marrow, which results in the production of abnormal antibodies. These antibodies, also called M proteins, cause the characteristic symptoms of multiple myeloma.
Symptoms of this cancer include bone pain, nausea, kidney problems, constipation, loss of appetite, confusion, mental fogginess, frequent infections, fatigue, weakness in the legs, weight loss, excessive thirst, hypercalcemia, and a low blood count. These symptoms are caused by an abnormal multiplication of plasma cells in the bone marrow. The reason behind this multiplication is unknown, but doctors suspect that chromosome 13 may be involved.
Multiple tests are used to diagnose multiple myeloma, including blood and urine tests, bone marrow exams, and imaging tests. After a diagnosis is confirmed, treatment consists of immunomodulatory drugs, proteasome inhibitors, chemotherapy, HDAC inhibitors, and steroids.
Sarclisa is a CD38-directed cytolytic antibody that is administered through IV. It is meant to help immune cells fight cancer cells. The FDA approved this treatment when taken in combination with pomalidomide and dexamethasone.
This approval came after the results of a trial including 307 participants, all of whom had relapsed or refractory multiple myeloma and received two prior treatments. Half of the participants received Sarclisa, with results being evaluated through progression free survival.
Those who received Sarclisa saw an improvement in progression free survival of 40%, along with a 60% overall response rate. It is these results that led to an Orphan Drug designation and approval from the FDA.
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