New Blood Cancer Rx Gets FDA Nod

FDA approves Sarclisa (isatuximab-irfc) to treat multiple myeloma

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new medication to treat multiple myeloma.

This new approval is called Sarclisa (isatuximab-irfc). It is to be given in combination with a steroid and pomalidomide.

The FDA approved this medication to treat adults with multiple myeloma who have tried at least two treatments. Administered into the vein, this drug helps certain cells attack cancer cells.

“Targeting cells has led to the development of important oncology treatments," said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases, in a press release. "While there is no cure for multiple myeloma, Sarclisa is now another CD38-directed treatment option added to the list of FDA-approved treatments of patients with multiple myeloma who have progressive disease after previous therapies. In the clinical trial, there was a 40 percent reduction in the risk of disease progression or death with this therapy.”

Multiple myeloma is a type of blood cancer. According to the National Cancer Institute, 32,270 new cases of multiple myeloma are estimated to occur in the United States this year.

Common side effects of Sarclisa included changes in blood cell counts, reactions associated with infusion, pneumonia and diarrhea. Serious side effects included serious infusion reactions and the risk of new cancers.

This medication can also lead to decreased white blood cell counts. Your health care provider will monitor you and your blood cell counts.

Sarclisa can affect the results of blood tests done to match or identify your blood type, the FDA noted. Before receiving blood transfusions, tell all of your health care providers you are being treated with this medication.

This medication's approval was granted to Sanofi-Aventis U.S. LLC.