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Zai Lab announces NDA acceptance of margetuximab for patients with pretreated metastatic HER2-positive breast cancer in China by the NMPA.

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Published:8th Jan 2022
Zai Lab Limited announced that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for margetuximab, an investigational, Fc-engineered monoclonal antibody that targets HER2.

The margetuximab NDA is for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease, in combination with chemotherapy.

“We are pleased to have NMPA’s acceptance of our NDA for margetuximab, which is the only HER2-targeted agent to have shown a progression-free survival (PFS) improvement versus trastuzumab in SOPHIA, a head-to-head global Phase III clinical trial,” said Alan Sandler, MD, President and Head of Global Development, Oncology, at Zai Lab. “Both SOPHIA and Zai Lab’s registrational bridging trial support the potential use of margetuximab as an important new treatment option for a very difficult-to-treat patient population. The potential approval of margetuximab will also be an important addition to our growing women’s oncology franchise and marks Zai Lab’s sixth NDA acceptance by the NMPA.”

“Early detection and treatment of breast cancer have had a positive impact on patient survival. However, we still need to improve the prognosis for people diagnosed with HER2-positive metastatic breast cancer, and additional anti-HER2 targeted therapies are needed,” said Professor Zefei Jiang, Chairman of Chinese Society of Clinical Oncology (CSCO) Breast Cancer Expert Committee and Deputy Director of Department of Oncology, Chinese PLA General Hospital. “Zai Lab’s bridging study confirmed the clinical benefit of margetuximab in Chinese patients. We are excited to see this potential new treatment option for patients living with metastatic breast cancer in China."

In December 2020, MacroGenics, Inc. announced that the FDA approved margetuximab (brand name Margenza) in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. The approval was based on efficacy and safety results from the pivotal Phase III SOPHIA trial.

In October 2021, Zai Lab announced that the bridging study of margetuximab plus chemotherapy as compared with trastuzumab plus chemotherapy in advanced, previously treated HER2-positive breast cancer patients met its primary endpoint, median PFS evaluated by blinded independent central review (BICR). The safety profile was consistent with that seen in the SOPHIA study. Zai Lab is planning to present the detailed study results at an upcoming medical conference. .

Condition: Breast Cancer HER2+
Type: drug

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