The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc), in combination with Pomalyst (pomalidomide) and dexamethasone, to treat adults with relapsed or refractory multiple myeloma who tried at least two prior lines of therapy, including Revlimid (lenalidomide) and a proteasome inhibitor.
Sarclisa, marketed by Sanofi, is expected to soon be available to patients in the U.S.
“Today’s FDA approval of Sarclisa provides a new treatment option for patients with difficult-to-treat multiple myeloma. These are patients whose disease has returned or become resistant to their prior treatments,” Paul Hudson, chief executive officer of Sanofi, said in a press release.
“Sarclisa offers a potential new standard of care in the United States,” Hudson aded. “We continue to evaluate Sarclisa in a comprehensive clinical program in multiple myeloma, as well as in other blood cancers and solid tumors.”
Sarclisa is a monoclonal antibody that targets and blocks the activity of CD38, a protein receptor found on the surface of multiple myeloma cells. Like other CD38 inhibitors, Sarclisa works to prevent the growth and expansion of malignant cancer cells, eventually killing them.
“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 … [for] patients with multiple myeloma who have progressive disease after previous therapies,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in its Center for Drug Evaluation and Research, said in an agency press release.
The FDA’s decision was based on data from a Phase 3 trial (NCT02990338), called ICARIA-MM, which evaluated the therapy’s safety and efficacy in relapsed or refractory multiple myeloma patients, when used in combination with Pomalyst and dexamethasone, a standard therapy.
ICARIA-MM enrolled 307 patients who had at least two prior lines of therapy, including Revlimid and a proteasome inhibitor. All were randomly assigned to either Sarclisa in combination with Pomalyst and low-dose dexamethasone, or Pomalyst plus dexamethasone alone.
Trial findings showed the addition of Sarclisa to this standard care regimen prolonged the time patients lived without disease worsening from 6.5 to 11.5 months, reducing the risk of death or disease progression by 40%.
This triple combination also increased the percentage of patients responding to treatment from 35.3% to 60.4%.
The most common adverse events reported included neutropenia, or low neutrophil counts (96%), infusion-related reactions (39%), pneumonia (31%), upper respiratory tract infection (57%), and diarrhea (26%). The percentage of patients who stopped treatment with Sarclisa due to severe adverse reactions was low (7%).
“The pivotal ICARIA-MM trial was the first Phase 3 study of a CD38 antibody in combination with pom-dex to present results demonstrating significant clinical benefit in this setting,” said Paul Richardson, MD, principal investigator of ICARIA-MM, and clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute.
“The study enrolled a broad population of patients with relapsed and refractory multiple myeloma that is particularly difficult to treat and with poor prognosis, which is reflective of real-world practice,” he added.
According to its prescribing information, Sarclisa should be administered intravenously at a dose of 10 mg/kg, in combination with Pomalyst and dexamethasone, every week for four weeks, and then every two weeks until disease progression or unacceptable toxicity.
Sarclisa’s U.S. list price is $650 per 100 mg vial, and at $3,250 per 500 mg vial, Sanofi reports. For a patient weighing between 70 and 80 kg (154–176 lbs), treatment would cost about $5,200 per infusion. Actual costs to patients, however, are likely to be lower than the medication’s current list price, the company notes, as this does not take into account insurance coverage, copay support, or financial assistance from support programs.
Patients in the U.S. prescribed Sarclisa may be eligible to enroll in Sanofi’s CareASSIST Patient Support Program, which provides reimbursement and financial support, and other information.