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[June 3, 2021] Roche Pharmaceuticals China announced that its subsidiary Jialuohua® (English name: Gazyva®, generic name: otuzumab) has been formally approved by the National Medical Products Administration (NMPA) of China, and is used for chemotherapy.
The combination is used for newly-treated adult patients with stage II and large masses, stage III or IV follicular lymphoma (FL), and patients who have achieved at least partial remission and are subsequently treated with monotherapy
.
The approval of Jialuohua®'s first-line treatment program brings new treatment options for patients with follicular lymphoma in China.
As the world's first glycosylated type II humanized anti-CD20 monoclonal antibody, Ortuzumab The innovative structure and mechanism of anti-tumor cells can enhance the killing power of tumor cells, so as to improve the progression-free survival rate of patients
.
Interpret the rhythm of life, significantly improve the quality of life of patients, and reduce recurrence.
The approval of Jialuohua® 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 follicular lymphoma (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 [1]
.
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) [2]
.
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 increase in PFS in patients with newly treated follicular lymphoma, and the proportion of POD24 events has dropped by nearly half, on average The evidence-based data with a 46% reduction in risk [2] is surprising
.
" Professor Ma Jun, director of the Harbin Institute of Hematology and Oncology, said, "At present, otuzumab has been included in many global guidelines including CSCO and NCCN guidelines.
The first-line recommendations of authoritative guidelines have become a new standard that is unanimously recognized by the first-line treatment of follicular lymphoma
.
"Twenty years of deep cultivation in the field, comprehensive expansion of the vision of lymphoma treatment" In the past 20 years, rituximab and its based programs It has always been the first-line treatment for patients with follicular lymphoma, and it 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, follicular lymphoma has been the first-line treatment .
Although the exploration of treatment is advancing all the way, the results have not been satisfactory; the GALLIUM study is the first clinical exploration to achieve the first-line treatment of newly diagnosed follicular lymphoma 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 treatment of follicular lymphoma
.
"Data shows that the incidence of follicular lymphoma in China has been increasing in recent years [3], and this type of tumor is usually difficult to cure
.
Most patients will experience repeated recurrences, and every time they relapse, the difficulty of treatment will increase.
, the more aggravated physical and psychological effects of stress treatment
.
as in 2020, "China survival of follicular lymphoma patients White Paper" (ask at the "White Paper") survey showed that follicular lymphoma patients plagued by repeated treatment, harbor The fear of recurrence makes it difficult to return to normal social life
.
Therefore, the first-line treatment of follicular lymphoma not only requires survival time (longer OS), but also tests the quality of life (longer PFS); further reduces recurrence, Obtaining a long-term and higher-quality survival is the most urgent hope for patients with follicular lymphoma
.
Otuzumab can meet this therapeutic need mainly due to its unique mechanism of action
.
As the world's first glycosylation engineering The structurally modified humanized type II anti-CD20 monoclonal antibody, compared with the control group human-mouse chimeric type I anti-CD20 monoclonal antibody, the otuzumab antibody relies on cell-mediated cytotoxicity (ADCC) and Antibody-dependent phagocytosis (ADCP) is enhanced by more than 35 times, and it can effectively enhance the direct cell killing effect, and overall reduce the risk of disease deterioration and recurrence
.
The statistical results of the "White Paper" also show that otuzumab is just follicular lymph.
One of the most anticipated new drugs for tumor 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
.
"[1] Marcus R, et al.
N Engl J Med 2017;377:1331–44.
[2] Launonen A et al.
ASH 2017.
Poster 1490.
[3] Guidelines for the diagnosis and treatment of follicular lymphoma in China (2013 edition).
Poke "read the original text" and we will make progress together
The combination is used for newly-treated adult patients with stage II and large masses, stage III or IV follicular lymphoma (FL), and patients who have achieved at least partial remission and are subsequently treated with monotherapy
.
The approval of Jialuohua®'s first-line treatment program brings new treatment options for patients with follicular lymphoma in China.
As the world's first glycosylated type II humanized anti-CD20 monoclonal antibody, Ortuzumab The innovative structure and mechanism of anti-tumor cells can enhance the killing power of tumor cells, so as to improve the progression-free survival rate of patients
.
Interpret the rhythm of life, significantly improve the quality of life of patients, and reduce recurrence.
The approval of Jialuohua® 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 follicular lymphoma (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 [1]
.
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) [2]
.
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 increase in PFS in patients with newly treated follicular lymphoma, and the proportion of POD24 events has dropped by nearly half, on average The evidence-based data with a 46% reduction in risk [2] is surprising
.
" Professor Ma Jun, director of the Harbin Institute of Hematology and Oncology, said, "At present, otuzumab has been included in many global guidelines including CSCO and NCCN guidelines.
The first-line recommendations of authoritative guidelines have become a new standard that is unanimously recognized by the first-line treatment of follicular lymphoma
.
"Twenty years of deep cultivation in the field, comprehensive expansion of the vision of lymphoma treatment" In the past 20 years, rituximab and its based programs It has always been the first-line treatment for patients with follicular lymphoma, and it 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, follicular lymphoma has been the first-line treatment .
Although the exploration of treatment is advancing all the way, the results have not been satisfactory; the GALLIUM study is the first clinical exploration to achieve the first-line treatment of newly diagnosed follicular lymphoma 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 treatment of follicular lymphoma
.
"Data shows that the incidence of follicular lymphoma in China has been increasing in recent years [3], and this type of tumor is usually difficult to cure
.
Most patients will experience repeated recurrences, and every time they relapse, the difficulty of treatment will increase.
, the more aggravated physical and psychological effects of stress treatment
.
as in 2020, "China survival of follicular lymphoma patients White Paper" (ask at the "White Paper") survey showed that follicular lymphoma patients plagued by repeated treatment, harbor The fear of recurrence makes it difficult to return to normal social life
.
Therefore, the first-line treatment of follicular lymphoma not only requires survival time (longer OS), but also tests the quality of life (longer PFS); further reduces recurrence, Obtaining a long-term and higher-quality survival is the most urgent hope for patients with follicular lymphoma
.
Otuzumab can meet this therapeutic need mainly due to its unique mechanism of action
.
As the world's first glycosylation engineering The structurally modified humanized type II anti-CD20 monoclonal antibody, compared with the control group human-mouse chimeric type I anti-CD20 monoclonal antibody, the otuzumab antibody relies on cell-mediated cytotoxicity (ADCC) and Antibody-dependent phagocytosis (ADCP) is enhanced by more than 35 times, and it can effectively enhance the direct cell killing effect, and overall reduce the risk of disease deterioration and recurrence
.
The statistical results of the "White Paper" also show that otuzumab is just follicular lymph.
One of the most anticipated new drugs for tumor 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
.
"[1] Marcus R, et al.
N Engl J Med 2017;377:1331–44.
[2] Launonen A et al.
ASH 2017.
Poster 1490.
[3] Guidelines for the diagnosis and treatment of follicular lymphoma in China (2013 edition).
Poke "read the original text" and we will make progress together
