Sanofi multiple myeloma drug approved for second indication by EC
The European Commission (EC) has approved a second indication of Sanofi’s Sarclisa drug for the treatment of adult patients with relapsed multiple myeloma (MM) who have received at least one prior therapy.
The medicine has been green-lighted following the Phase III IKEMA study in 302 patients with relapsed MM, which demonstrated that Sarclisa, added to standard of care carfilzomib and dexamethasone, reduced risk of disease progression or death by 47% in patients who had relapsed after one to three prior therapies.
The study also found that, while progression free survival (PFS) for those with standard care was 19.15 months, median PFS for patients receiving Sarclisa as well had not been reached at the time of the interim analysis.
This marks the second EC approval of Sarclisa in combination with a standard of care regimen in less than 12 months, while the FDA in the US approved Sarclisa for a similar indication in March.
In June last year, Sarclisa received EC approval in combination with another standard of care regimen, pomalidomide and dexamethasone (pom-dex), for the treatment of adult patients with relapsed and refractory MM, who have received at least two prior therapies and have demonstrated disease progression on the last therapy.
MM is the second most common hematologic malignancy, with more than 130,000 new diagnoses of MM worldwide per year. Relapsed MM is the term for when the cancer returns after treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy.
Dr Philippe Moreau, Department of Hematology at University Hospital of Nantes, said: “As there is no cure for multiple myeloma and patients often experience disease relapse, we must persist in our pursuit for additional treatment options. Nearly 30% of patients treated with the Sarclisa regimen had a profound response with undetectable levels of multiple myeloma.
“This new therapeutic regimen has the potential to become a standard of care for patients with relapsed multiple myeloma, who now have another treatment option earlier in the progression of their disease.”
Peter C Adamson, Global Development Head of Oncology and Pediatric Innovation at Sanofi, added: “The EC approval of Sarclisa in combination with carfilzomib and dexamethasone means patients living with multiple myeloma in Europe can now receive Sarclisa in combination with two standard of care treatment regimens.
“The carfilzomib and dexamethasone combination represents an important standard of care in Europe. The Phase III IKEMA trial’s finding that the addition of Sarclisa to this regimen reduced the risk of progression or death by nearly half formed the basis for this important EC approval.”
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