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▎The content team editor of WuXi AppTec today, Sanofi announced that the US FDA has approved its CD38 antibody Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone (Kd) standard therapies to treat relapse/difficulty Treatment of multiple myeloma (MM) patients.
These patients have received 1-3 pre-treatments.
This is Sarclisa's second FDA approval.
MM is the second most common hematological malignancy.
There are more than 130,000 newly diagnosed MM patients worldwide each year.
Despite the available treatments, MM is still an incurable malignant tumor and is associated with a significant patient burden.
Since there is no cure for MM, most patients will relapse.
Recurrent MM refers to the recurrence of cancer after treatment or after the remission period.
Sarclisa is a monoclonal antibody that specifically binds to the CD38 receptor expressed on MM cells.
It works through multiple mechanisms of action, including programmed tumor cell death (apoptosis) and immunomodulatory activity.
CD38 is highly uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutic drugs such as Sarclisa.
The FDA approval is based on the results of the randomized, double-blind, open-label phase 3 clinical trial IKEMA.
The test results showed that compared with standard Kd therapy, Sarclisa combination therapy reduced the risk of disease progression or death by 45% (HR=0.
548, p=0.
0032).
As of the interim analysis, the median progression-free survival (PFS) of the Kd treatment group was 19.
15 months, while the median PFS of the patients receiving the Sarclisa combination therapy had not been reached. "The treatment of patients with relapsed/refractory MM is still challenging, and the prognosis for patients who have experienced multiple relapses is poor.
" said Dr.
Peter C.
Adamson, head of Sanofi's Oncology and Pediatric Innovation Global Development.
"This approval marks Sarclisa has been included in two standard treatment options, and MM patients can be treated after they relapse for the first time.
"In China, isatuximab was approved for clinical use in July last year and is intended to treat high-risk smoking multiple myeloma.
It is also conducting two clinical trials in China: one is a randomized, open, international multicenter phase 3 clinical trial, which aims to compare isatuximab combined with bortezomib, lenalidomide and dexamethasone, and bortezomib and lena.
Compared with dexamethasone, the benefit of medosamine in prolonging the progression-free survival of patients newly diagnosed with multiple myeloma and not suitable for transplantation; the other is a phase 1 clinical study, which aims to evaluate isatuximab for recurrence and/ Or the pharmacokinetics, safety and preliminary efficacy of Chinese patients with refractory multiple myeloma.
Reference: [1] FDA approves Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma.
Retrieved March 31, 2021, from /03/31/2202919/0/en/FDA-approves-Sarclisa-isatuximab-in-combination-with-carfilzomib-and-dexamethasone-for-patients-with-relapsed-or-refractory-multiple-myeloma.
htmlNote: This article aims to introduce the progress of medical and health research, not to recommend treatment options. If you need guidance on treatment plans, please go to a regular hospital for treatment.
These patients have received 1-3 pre-treatments.
This is Sarclisa's second FDA approval.
MM is the second most common hematological malignancy.
There are more than 130,000 newly diagnosed MM patients worldwide each year.
Despite the available treatments, MM is still an incurable malignant tumor and is associated with a significant patient burden.
Since there is no cure for MM, most patients will relapse.
Recurrent MM refers to the recurrence of cancer after treatment or after the remission period.
Sarclisa is a monoclonal antibody that specifically binds to the CD38 receptor expressed on MM cells.
It works through multiple mechanisms of action, including programmed tumor cell death (apoptosis) and immunomodulatory activity.
CD38 is highly uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutic drugs such as Sarclisa.
The FDA approval is based on the results of the randomized, double-blind, open-label phase 3 clinical trial IKEMA.
The test results showed that compared with standard Kd therapy, Sarclisa combination therapy reduced the risk of disease progression or death by 45% (HR=0.
548, p=0.
0032).
As of the interim analysis, the median progression-free survival (PFS) of the Kd treatment group was 19.
15 months, while the median PFS of the patients receiving the Sarclisa combination therapy had not been reached. "The treatment of patients with relapsed/refractory MM is still challenging, and the prognosis for patients who have experienced multiple relapses is poor.
" said Dr.
Peter C.
Adamson, head of Sanofi's Oncology and Pediatric Innovation Global Development.
"This approval marks Sarclisa has been included in two standard treatment options, and MM patients can be treated after they relapse for the first time.
"In China, isatuximab was approved for clinical use in July last year and is intended to treat high-risk smoking multiple myeloma.
It is also conducting two clinical trials in China: one is a randomized, open, international multicenter phase 3 clinical trial, which aims to compare isatuximab combined with bortezomib, lenalidomide and dexamethasone, and bortezomib and lena.
Compared with dexamethasone, the benefit of medosamine in prolonging the progression-free survival of patients newly diagnosed with multiple myeloma and not suitable for transplantation; the other is a phase 1 clinical study, which aims to evaluate isatuximab for recurrence and/ Or the pharmacokinetics, safety and preliminary efficacy of Chinese patients with refractory multiple myeloma.
Reference: [1] FDA approves Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma.
Retrieved March 31, 2021, from /03/31/2202919/0/en/FDA-approves-Sarclisa-isatuximab-in-combination-with-carfilzomib-and-dexamethasone-for-patients-with-relapsed-or-refractory-multiple-myeloma.
htmlNote: This article aims to introduce the progress of medical and health research, not to recommend treatment options. If you need guidance on treatment plans, please go to a regular hospital for treatment.
