BeiGene Ltd. (NASDAQ: BGNE) has announced the acceptance of its marketing authorization application for BRUKINSA by Swissmedic. BRUKINSA is a treatment alternative the company is developing for the treatment of patients with Waldenstrom’s macroglobulinemia.
Swissmedic reviewing BRUKINSA MAA
Swissmedic, the Swiss Agency for Therapeutic Products, has commenced formal reviews of the BRUKINSA MAA. Already the agency has granted BRUKINSA an orphan drug status. Within the process of MAA review, the agency will evaluate the safety, efficacy, and quality of the product through clinical study data.
BeiGene’s SVP Head of Commercial, Europe, Gerwin Winter, said, “The acceptance of the marketing authorization application of BRUKINSA by Swissmedic is a crucial step in the development of BRUKINSA for Swiss patients with WM. We are looking forward to continuing our work with the health authorities to bring BRUKINSA to patients living with this rare, incurable blood cancer.”
The company supported the MAA with data from its randomized phase III ASPEN clinical study evaluating zanubrutinib relative to ibrutinib in adult WM patients. Swissmedic’s approval will give the company marketing authorization in Switzerland for BRUKINSA in WM.
QARZIBA receives conditional approval in China
The company has also announced that China National Medical Products Administration has granted conditional approval for dinutuximab beta (QARZIBA). The approval is for treating high-risk neuroblastoma patients above 12 months that had received induction chemotherapy before and attained a partial response followed by stem cell transplantation or myeloablative therapy. Equally, the treatment has approval for treatment of patients with a history of refractory or relapsed neuroblastoma without or with residual diseases. In addition, QARZIBA has targeted immunotherapy with EMA approval.
BeiGene China COO and General Manager Xiaobun Wu said, “Dinutuximab beta represents an important biologic therapy for pediatric patients in China, having been listed in the first batch of New Drugs in Urgent Clinical Need Marketed Overseas by the NMPA. For these young patients fighting neuroblastoma in China, we are proud to bring the first approved treatment.”
