Roche's new generation of anti-CD20 monoclonal antibody Jialuohua® was approved in China!

On June 3, 2021, Roche Pharmaceuticals China announced that Jialuohua® (English name: Gazyva®, generic name: otuzumab) has been formally approved by the China National Medical Products Administration for use in combination with chemotherapy.
Adult patients with stage II and stage III or IV follicular lymphoma who are treated for stage II with giant masses, and those who have achieved at least partial remission receive subsequent single-agent maintenance therapy
.
The approval of Jialuohua®'s first-line treatment plan brings new treatment options for patients with follicular lymphoma in China

Improve patient quality of life and reduce recurrence

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.

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 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 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]
.

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
.

Deeply cultivated in the field for 20 years, comprehensively expand the vision of lymphoma treatment

Data show that the incidence of follicular lymphoma in China has been increasing in recent years [3], and such tumors are usually difficult to cure
.
Most patients will experience repeated relapses, and every time they relapse, the difficulty of treatment will escalate, increasing physical and mental stress and affecting treatment

As shown in the 2020 "White Paper on Survival Status of Patients with Follicular Lymphoma in China" (hereinafter referred to as the "White Paper") survey, patients with follicular lymphoma are deeply troubled by repeated treatments and have fear of recurrence, making it difficult to return to normal.
Social life
.
Therefore, the first-line treatment of FL not only requires survival time (longer OS), but also tests the quality of life (longer PFS); further reducing recurrences and obtaining long-term and higher-quality survival are the most urgent hopes for FL patients

       Otuzumab's ability to meet this therapeutic need is 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 control group human-mouse chimeric type I anti-CD20 monoclonal antibody, the otuzumab antibody relies on cell mediation.

       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 and improve the survival benefits of lymphoma patients.

.
We are very pleased that Jia Luohua ® has been approved in China this time, adhering to the concept of "Patients First", Roche will continue to cultivate in the field of blood diseases, and look forward to providing more innovative and effective solutions for Chinese patients in the future

       references:

       [1] Marcus R, et al.

       [2] Launonen A et al.