Silver Spring, MD (Press Release) – 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.

“Targeting cells has led to the devel­op­ment of im­por­tant on­col­ogy treat­ments. 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,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “In the clin­i­cal trial, there was a 40% re­duc­tion in the risk of dis­ease pro­gres­sion or death with this ther­apy.”

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. The dis­ease may result in a weakened immune sys­tem and cause other bone or kidney problems. The National Cancer Institute esti­mates there would be 32,270 new cases of multiple myeloma and 12,830 related deaths in the United States in 2020.

The FDA approved Sarclisa based on the results of a clin­i­cal trial involving 307 patients with re­lapsed and re­frac­tory multiple myeloma who had re­ceived at least two prior ther­a­pies, in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor. Half of the patients re­ceived Sarclisa in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone and the other half re­ceived only poma­lido­mide and low-dose dexa­meth­a­sone. The efficacy of Sarclisa was based on pro­gres­sion-free sur­vival (PFS) – the amount of time a patient stays alive without the cancer growing. Patients who re­ceived Sarclisa in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone showed im­prove­ment in PFS with a 40% re­duc­tion in the risk of dis­ease pro­gres­sion or death com­pared to patients who re­ceived poma­lido­mide and dexa­meth­a­sone. These patients also had an over­all re­sponse­ rate of 60.4%. In comparison, the patients who only re­ceived poma­lido­mide and low-dose dexa­meth­a­sone had an over­all re­sponse­ rate of 35.3%.

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.

Sarclisa re­ceived Orphan Drug desig­na­tion, which provides incentives to assist and en­cour­age the devel­op­ment of drugs for rare dis­eases.

The FDA granted ap­­prov­al of Sarclisa to Sanofi-Aventis U.S. LLC.

The FDA, an agency within the U.S. Department of Health and Human Services, pro­tects the public health by assuring the safety, effectiveness, and se­cu­ri­ty of human and veterinary drugs, vaccines and other biological prod­ucts for human use, and medical devices. The agency also is responsible for the safety and se­cu­ri­ty of our nation’s food supply, cosmetics, dietary supple­ments, prod­ucts that give off electronic radi­a­tion, and for regulating tobacco prod­ucts.

Source: Food and Drug Admin­istra­tion.