The U.S. Food and Drug Administration said on Friday it has approved the use of a drug combination along with Sanofi’s Sarclisa infusion as a treatment for certain types of newly diagnosed multiple myeloma patients.
Sarclisa has previously been approved for use as a fallback therapy for certain cases of multiple myeloma after standard treatments have failed.
The French drugmaker, a market leader in anti-inflammatory drugs, has underscored its commitment to oncology drug development even after a once-promising breast cancer drug candidate flopped in 2022.
The FDA’s approval allows use of the regimen in patients who are not eligible for autologous stem cell transplant, another treatment option for multiple myeloma.
In a late-stage study, a certain treatment regimen with Sarclisa lowered the risk of disease progression or death by 40% when compared to a treatment course without Sarclisa.
The study was conducted in patients who were not eligible for the autologous stem cell transplant, in which a patient’s own healthy blood cells are used to restore bone marrow function.
The drug was given FDA priority review status in May.
Sanofi plans to advance blood cancer drugs known as anti-CD38, which include Sarclisa, despite GenMab and Johnson & Johnson’s strong foothold with Darzalex in the same class.
Sarclisa generated sales of 227 million euros ($253.40 million)in the first half of the year. Analysts expect annual Sarclisa sales of about 800 million-900 million euros by 2030, according to LSEG data.
($1 = 0.8958 euros)
(Reporting by Ludwig Burger)
