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A few days ago, another blockbuster innovative drug has been added to the field of lymphoma treatment, the new generation of anti-CD20 monoclonal antibody Jialuohua® (English name: Gazyva®, generic name: otuzumab) has officially been approved by the National Medical Products Administration (NMPA) of China Approved, combined with chemotherapy, for initial treatment of stage II adult patients with large masses, stage III or IV follicular lymphoma, and patients who have achieved at least partial remission and subsequent single-agent maintenance therapy
.
The approval of Jialuohua®'s first-line treatment program brings new treatment options for patients with follicular lymphoma (FL) in China.
As the world's first glycosylated type II humanized anti-CD20 monoclonal antibody, Austria The innovative structure and mechanism of touzumab can enhance the killing power of tumor cells, so as to improve the progression-free survival rate of patients
.
Patients with a reduced risk of recurrence have significant clinical benefits.
The approval of Jalova® is based on the global Phase III GALLIUM study
.
This pivotal study aims to compare the efficacy of otuzumab combined with chemotherapy, followed by otuzumab monotherapy for two years, and rituximab combined with chemotherapy, followed by rituximab monotherapy for two years.
And safety
.
A total of 1202 patients with advanced FL (stage II large mass, stage III or IV) were enrolled
.
The results of the study showed that after a median follow-up of 34.
5 months, compared with the standard treatment regimen in the control group, the combination of otuzumab chemotherapy can significantly reduce the risk of progression/recurrence or death by 34%, and a progression-free survival period Significantly prolonged (three-year PFS rate was 80.
0% vs.
73.
3%, HR=0.
66; 95% CI: 0.
51-0.
85; p=0.
0012), reaching the primary study endpoint
.
In terms of the early progression of follicular lymphoma, otuzumab combined with chemotherapy can significantly reduce the cumulative incidence of disease progression (POD24) within 24 months, and reduce the risk of early progression by 46% (9% vs.
16%) , HR=0.
54; 95% CI: 0.
39-0.
75)
.
The study also conducted continuous follow-up, and the 5-year long-term data conclusions further confirmed the long-term benefits of otuzumab in reducing the risk of disease recurrence and death (PFS and POD24)
.
In addition, the safety data confirmed that the application of the otuzumab treatment regimen was consistent with the previously known safety data, and no new or unexpected safety signals were found
.
"First-line treatment is an important basis for formulating overall treatment strategies and improving the overall survival benefits of patients
.
Otuzumab combined with chemotherapy has achieved a significant improvement in PFS in patients with newly treated follicular lymphoma, and the disease progressed within 24 months (POD24).
) The proportion of incidents has dropped by nearly half, and the average risk has dropped by 46%2.
The evidence-based data is surprising
.
” Professor Ma Jun, director of the Harbin Institute of Hematology and Oncology, said, “At present, otuzumab has been included in CSCO and NCCN.
The first-line recommendation of many authoritative guidelines around the world, including the guidelines, has become a new standard that is unanimously recognized by the first-line treatment of follicular lymphoma
.
"Unique mechanism meets the treatment needs and establishes a new standard for first-line treatment of FL.
" In the past 20 years, rituximab has been used Its-based program has always been the first-line treatment for patients with follicular lymphoma, and has brought significant survival benefits to patients
.
" Professor Zhu Jun, Secretary of the Party Committee and Director of the Lymphoma Department of Peking University Cancer Hospital, said, "In recent years, Although the exploration of the first-line treatment of follicular lymphoma is advancing all the way, the results have always been unsatisfactory; the GALLIUM study is the first clinical exploration to achieve a first-line treatment of newly diagnosed FL patients to significantly reduce the risk of disease recurrence and death
.
Based on this, the arrival of otuzumab is not only expected to realize the patient's desire to reduce the risk of recurrence and death, and to have a better life; it can also bring a positive impact on subsequent treatment
.
Therefore, this approval is a landmark for the FL treatment field
.
"Data shows that the incidence of follicular lymphoma in China has been increasing in recent years, and this type of tumor is usually difficult to cure
.
Most patients will experience repeated relapses, and with each relapse, the difficulty of treatment will escalate and become more and more serious.
Physical and psychological stress affects treatment
.
As the 2020 "White Paper on Survival Status of Patients with Follicular Lymphoma in China" (hereinafter referred to as the "White Paper") survey shows, patients with follicular lymphoma are deeply troubled by repeated treatments and fear recurrence.
, It is difficult to return to normal social life
.
Therefore, first-line treatment of FL not only requires survival time (longer OS), but also tests the quality of life (longer PFS); further reduces recurrences and obtains a long-term and higher-quality survival It is the most urgent hope of FL patients
.
Otuzumab can meet this therapeutic need mainly due to its unique mechanism of action
.
As the world's first humanized type II anti-CD20 monoclonal antibody modified by glycosylation engineering structure Compared with the human-mouse chimeric type I anti-CD20 monoclonal antibody in the control group, the cell-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent phagocytosis (ADCP) of the Altuzumab antibody were enhanced by 35 times.
The above, and can effectively enhance the direct cell killing effect, and reduce the overall risk of disease deterioration and recurrence
.
The statistical results of the "White Paper" also show that most of the interviewed patients with follicular lymphoma have an urgent need for new drugs, and otuzumab It is one of the most anticipated new drugs for patients
.
Ms.
Zhou Hong, President of Roche Pharmaceuticals China, said: "Roche has a deep heritage in the field of blood diseases, and has been continuously developing innovative drugs in the field of blood diseases for 20 years.
We actively cooperate with all parties in China to promote the overall diagnosis and treatment of lymphoma.
level, and improve the survival benefit in patients with lymphoma
.
we are pleased to present the second best rituximab ® approved in China, adhering to the 'first of the line to be patient', and Roche will continue to deep plowing in the field of blood diseases, and look forward to in the future Chinese patients provide more innovative and effective solutions
.
"Summary At present, the approval of otuzumab has ushered the treatment of follicular lymphoma in China into a new era
.
In the future, as a new generation of humanized anti-CD20 monoclonal antibody, the application of otuzumab in the entire field of lymphoma treatment is also expected to continue to expand, bringing new treatment options to more patients, whether it is otuzumab The development of the "de-chemotherapy" regimen combined with lenalidomide in the first-line treatment of patients with high tumor burden follicular lymphoma is a further exploration of the indications for chronic lymphocytic leukemia and small lymphocytic lymphoma that have been approved by the global drug regulatory authority , Are constantly achieving new results
.
We have reason to believe that in the future, patients with more lymphoma will surely get more life bargaining chips, and get a longer and higher-quality survival time
.
.
The approval of Jialuohua®'s first-line treatment program brings new treatment options for patients with follicular lymphoma (FL) in China.
As the world's first glycosylated type II humanized anti-CD20 monoclonal antibody, Austria The innovative structure and mechanism of touzumab can enhance the killing power of tumor cells, so as to improve the progression-free survival rate of patients
.
Patients with a reduced risk of recurrence have significant clinical benefits.
The approval of Jalova® is based on the global Phase III GALLIUM study
.
This pivotal study aims to compare the efficacy of otuzumab combined with chemotherapy, followed by otuzumab monotherapy for two years, and rituximab combined with chemotherapy, followed by rituximab monotherapy for two years.
And safety
.
A total of 1202 patients with advanced FL (stage II large mass, stage III or IV) were enrolled
.
The results of the study showed that after a median follow-up of 34.
5 months, compared with the standard treatment regimen in the control group, the combination of otuzumab chemotherapy can significantly reduce the risk of progression/recurrence or death by 34%, and a progression-free survival period Significantly prolonged (three-year PFS rate was 80.
0% vs.
73.
3%, HR=0.
66; 95% CI: 0.
51-0.
85; p=0.
0012), reaching the primary study endpoint
.
In terms of the early progression of follicular lymphoma, otuzumab combined with chemotherapy can significantly reduce the cumulative incidence of disease progression (POD24) within 24 months, and reduce the risk of early progression by 46% (9% vs.
16%) , HR=0.
54; 95% CI: 0.
39-0.
75)
.
The study also conducted continuous follow-up, and the 5-year long-term data conclusions further confirmed the long-term benefits of otuzumab in reducing the risk of disease recurrence and death (PFS and POD24)
.
In addition, the safety data confirmed that the application of the otuzumab treatment regimen was consistent with the previously known safety data, and no new or unexpected safety signals were found
.
"First-line treatment is an important basis for formulating overall treatment strategies and improving the overall survival benefits of patients
.
Otuzumab combined with chemotherapy has achieved a significant improvement in PFS in patients with newly treated follicular lymphoma, and the disease progressed within 24 months (POD24).
) The proportion of incidents has dropped by nearly half, and the average risk has dropped by 46%2.
The evidence-based data is surprising
.
” Professor Ma Jun, director of the Harbin Institute of Hematology and Oncology, said, “At present, otuzumab has been included in CSCO and NCCN.
The first-line recommendation of many authoritative guidelines around the world, including the guidelines, has become a new standard that is unanimously recognized by the first-line treatment of follicular lymphoma
.
"Unique mechanism meets the treatment needs and establishes a new standard for first-line treatment of FL.
" In the past 20 years, rituximab has been used Its-based program has always been the first-line treatment for patients with follicular lymphoma, and has brought significant survival benefits to patients
.
" Professor Zhu Jun, Secretary of the Party Committee and Director of the Lymphoma Department of Peking University Cancer Hospital, said, "In recent years, Although the exploration of the first-line treatment of follicular lymphoma is advancing all the way, the results have always been unsatisfactory; the GALLIUM study is the first clinical exploration to achieve a first-line treatment of newly diagnosed FL patients to significantly reduce the risk of disease recurrence and death
.
Based on this, the arrival of otuzumab is not only expected to realize the patient's desire to reduce the risk of recurrence and death, and to have a better life; it can also bring a positive impact on subsequent treatment
.
Therefore, this approval is a landmark for the FL treatment field
.
"Data shows that the incidence of follicular lymphoma in China has been increasing in recent years, and this type of tumor is usually difficult to cure
.
Most patients will experience repeated relapses, and with each relapse, the difficulty of treatment will escalate and become more and more serious.
Physical and psychological stress affects treatment
.
As the 2020 "White Paper on Survival Status of Patients with Follicular Lymphoma in China" (hereinafter referred to as the "White Paper") survey shows, patients with follicular lymphoma are deeply troubled by repeated treatments and fear recurrence.
, It is difficult to return to normal social life
.
Therefore, first-line treatment of FL not only requires survival time (longer OS), but also tests the quality of life (longer PFS); further reduces recurrences and obtains a long-term and higher-quality survival It is the most urgent hope of FL patients
.
Otuzumab can meet this therapeutic need mainly due to its unique mechanism of action
.
As the world's first humanized type II anti-CD20 monoclonal antibody modified by glycosylation engineering structure Compared with the human-mouse chimeric type I anti-CD20 monoclonal antibody in the control group, the cell-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent phagocytosis (ADCP) of the Altuzumab antibody were enhanced by 35 times.
The above, and can effectively enhance the direct cell killing effect, and reduce the overall risk of disease deterioration and recurrence
.
The statistical results of the "White Paper" also show that most of the interviewed patients with follicular lymphoma have an urgent need for new drugs, and otuzumab It is one of the most anticipated new drugs for patients
.
Ms.
Zhou Hong, President of Roche Pharmaceuticals China, said: "Roche has a deep heritage in the field of blood diseases, and has been continuously developing innovative drugs in the field of blood diseases for 20 years.
We actively cooperate with all parties in China to promote the overall diagnosis and treatment of lymphoma.
level, and improve the survival benefit in patients with lymphoma
.
we are pleased to present the second best rituximab ® approved in China, adhering to the 'first of the line to be patient', and Roche will continue to deep plowing in the field of blood diseases, and look forward to in the future Chinese patients provide more innovative and effective solutions
.
"Summary At present, the approval of otuzumab has ushered the treatment of follicular lymphoma in China into a new era
.
In the future, as a new generation of humanized anti-CD20 monoclonal antibody, the application of otuzumab in the entire field of lymphoma treatment is also expected to continue to expand, bringing new treatment options to more patients, whether it is otuzumab The development of the "de-chemotherapy" regimen combined with lenalidomide in the first-line treatment of patients with high tumor burden follicular lymphoma is a further exploration of the indications for chronic lymphocytic leukemia and small lymphocytic lymphoma that have been approved by the global drug regulatory authority , Are constantly achieving new results
.
We have reason to believe that in the future, patients with more lymphoma will surely get more life bargaining chips, and get a longer and higher-quality survival time
.
