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Posted On: 04/01/2021 6:52:22 PM
Post# of 148902
A monoclonal antibody approved- Sarclisa.
Could this be seen as a postive indication? Example- that, even though different than leron, FDA is getting more familiar with monoclonal antibody treatments? Approving to be used in combo with other treatments?
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Sanofi won approval for Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy.
Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.
The approval was based on the Phase III IKEMA study. Data from the study showed the addition of Sarclisa to carfilzomib and dexamethasone reduced risk of disease progression or death by 45%. In the secondary endpoint of overall response rate (ORR) there was no statistical difference between the Sarclisa arm and the control arm. They were similar at 86.6% for the Sarclisa combination therapy versus 82.9% for Kd alone. The complete response rate was 39.7% in the Sarclisa combination therapy arm and 27.6% in the Kd arm.
FDA Approves Monoclonal Antibody]
Could this be seen as a postive indication? Example- that, even though different than leron, FDA is getting more familiar with monoclonal antibody treatments? Approving to be used in combo with other treatments?
___________________________________________
Sanofi won approval for Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy.
Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.
The approval was based on the Phase III IKEMA study. Data from the study showed the addition of Sarclisa to carfilzomib and dexamethasone reduced risk of disease progression or death by 45%. In the secondary endpoint of overall response rate (ORR) there was no statistical difference between the Sarclisa arm and the control arm. They were similar at 86.6% for the Sarclisa combination therapy versus 82.9% for Kd alone. The complete response rate was 39.7% in the Sarclisa combination therapy arm and 27.6% in the Kd arm.
FDA Approves Monoclonal Antibody]
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