Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its novel lymphoma therapy, Columvi (glofitamab). The drug is now approved to treat adult patients with recurrent or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least two lines of systemic treatment.
Approval Based on Positive Study Results
The approval comes on the heels of the positive results from the NP30179 study, which demonstrated that patients with R/R DLBCL treated with a fixed duration of glofitamab achieved a sustained response. The study reported a complete response (CR) rate of 40%, an objective response rate (ORR) of 52%, and a median complete response (CR) duration of 26.9 months.
Glofitamab’s Mechanism and Advantages
Glofitamab is a bispecific antibody (BsAb) developed on Roche’s TCB technology platform, which binds bivalently to CD20 on B cells and monovalently to CD3 on T cells. This unique structure allows for a higher binding ability to CD20 compared to traditional 1:1 dual antibodies, inducing rapid T cell activation and cytokine release, leading to target cell lysis. The 2:1 dual antibody structure also enables the potential for combination with other types of anti-CD20 antibodies, opening up possibilities for subsequent research and development of combined therapy plans.
Breakthrough Therapy Designation and Priority Review
Glofitamab was awarded breakthrough therapy designation (BTD) in China in August 2021 for the treatment of R/R DLBCL after two or more systemic treatments, including diffuse large B cell lymphoma-non-specific type (DLBCL-NOS), advanced B-cell lymphoma (HGBCL), follicular lymphoma transformed DLBCL (trFL), and primary mediastinal large B-cell lymphoma (PMBCL). The drug also earned priority review status in January this year in China, highlighting its potential impact on the treatment landscape for lymphoma patients.- Flcube.com
