Roche's MabThera® Gains Two New Indications in China, Benefiting More Patients with Hematologic Diseases

Shanghai, December 11, 2019 /PRNewswire/ -- Roche Pharma China announced that MabThera® (generic name: rituximab) has received formal approval from the National Medical Products Administration (NMPA) of China for two indications: as monotherapy maintenance treatment in patients with previously untreated follicular lymphoma (FL) who have achieved complete or partial response following induction therapy with MabThera combined with chemotherapy; and in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL).

Significantly Reduces the Risk of Follicular Lymphoma Progression, Offering Greater Hope for Patient Cure

Professor Ma Jun, Director of the Harbin Institute of Hematology and Oncology, stated, “Follicular lymphoma is the most common indolent B-cell non-Hodgkin lymphoma in China, with a high incidence among middle-aged and elderly populations. It is relatively difficult to achieve a complete cure, and a significant proportion of patients experience disease progression within 3–5 years after initial treatment. With each recurrence, the remission period becomes progressively shorter, and the likelihood of refractory disease increases, leading to reduced overall survival. Therefore, maintenance therapy is crucial to reduce or delay recurrence. This time, MabThera^®“The approval of maintenance therapy indications for FL is conducive to achieving better quality of life and longer survival for patients with follicular lymphoma.”

The National Medical Products Administration of China has approved MabThera^®The indication for FL monotherapy maintenance treatment is primarily based on the PRIMA study.^[1]Analysis results showed that 82% of patients receiving Rituximab maintenance therapy remained free from disease progression or worsening (progression-free survival, PFS) within two years. Compared with the observation group, Rituximab maintenance therapy significantly reduced the risk of disease progression by 50%. Follow-up results at 9.8 years indicated that the median PFS was 10.5 years in patients undergoing maintenance therapy, compared to only 4.1 years in the observation group. In the Rituximab maintenance group, more than half of the patients remained free from disease progression (with a 38% reduction in the risk of disease progression) or did not require new anti-lymphoma therapy (with a 33% reduction in the risk of retreatment).^[2]。

Professor Zhu Jun, Director of the Lymphoma Department at Peking University Cancer Hospital, pointed out: “First-line treatment is a crucial foundation for improving overall survival (OS). The Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Lymphoma recommend that high-risk patients undergo two years of rituximab maintenance or consolidation therapy after first-line immunochemotherapy, to prolong remission and improve progression-free survival (PFS). Real-world study data in China suggest that the three-year OS rate can exceed 90% in patients with follicular lymphoma who receive standardized first-line therapy based on rituximab. In other words, initiating standardized treatment in strict accordance with domestic and international guidelines from the first-line setting can reduce or delay patient relapse.”

New Treatment Options for Chronic Lymphocytic Leukemia in China，Improving Patient Survival Benefit

Concurrent with the approval of the new indication for maintenance therapy in follicular lymphoma (FL), MabThera^®The indication for (rituximab) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL) has also received formal approval from the National Medical Products Administration (NMPA).

This approval was primarily based on the CLL-8 study, which demonstrated that compared with FC chemotherapy alone (fludarabine and cyclophosphamide), the FCR regimen (rituximab combined with fludarabine and cyclophosphamide) doubled the complete response (CR) rate (44% vs. 22%), significantly improved the overall response rate (ORR) (90% vs. 80%), significantly prolonged median progression-free survival (PFS) (51.8 months vs. 32.8 months), and yielded a more pronounced benefit in overall survival (OS) (3-year OS: 87% vs. 83%).^[3]。

Professor Li Jianyong, Director of the Department of Hematology at the First Affiliated Hospital of Nanjing Medical University, pointed out: “Chronic lymphocytic leukemia (CLL) is an indolent tumor with a relatively slow progression and is one of the most common types of adult leukemia, primarily affecting middle-aged and elderly individuals. In the history of CLL treatment, rituximab has been the most commonly used agent internationally. In clinical practice, it is generally combined with other chemotherapeutic drugs to improve the complete remission rate and prolong patient survival, constituting the standard chemotherapy regimen.”

In this regard, Professor Zhao Weili, Executive Deputy Director of the Department of Hematology at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, emphasized, “Currently, rituximab-based treatment regimens can significantly improve clinical symptoms in the majority of patients with chronic lymphocytic leukemia (CLL), prolong progression-free survival (PFS), and achieve effective disease control, with treatment-related side effects being manageable and predictable. At present, the therapeutic goal for CLL is to extend patients’ PFS as much as possible. In this context, the approval of new indications holds substantial significance for patients with chronic lymphocytic leukemia.”

Ms. Zhou Hong, President of Roche Pharma Chinastated: “Twenty years ago, the approval of MabThera® (rituximab) in China rewrote the history of lymphoma treatment in the country. We are delighted that, two decades after its introduction to the Chinese market, MabThera® has received approval for two new indications. Adhering to our philosophy of ‘acting in accordance with patients’ needs,’ we have never ceased our innovative R&D efforts in the field of hematologic diseases. Alongside the continuously accelerating review and approval process for new drugs in China, we remain committed to facilitating the entry of more novel hematologic therapies into the Chinese market, thereby providing better options and hope for the vast number of Chinese patients with hematologic diseases.”

[1] SallesG, SeymourJF, OffnerF，et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy(PRIMA): a phase 3，randomised controlled trial[J]. Lancet，2011，377(9759):42-51.

[2] SallesGA, SeymourJF, FeugierP，et al. Long term follow-up of the PRIMA study：half of patients receiving rituximab maintenance remain progression free at 10 years[J]. Blood，2017，130Suppl 1:486.

[3] Fischer K , Bahlo J , Fink A M , et al. Long term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial.[J]. Blood, 2016, 127(2):208-215.