New indications for Roche (RHHBY.US) gefitumab approved in China

Zhitong Finance App learned that on May 7, Roche (RHHBY.US) (Roche) announced that the marketing application for a new indication of gefitumab injection has been approved by the China National Drug Administration (NMPA), in combination with gemcitabine and oxaliplatin (GeMoX) for the treatment of recurrent or refractory diffuse large B-cell lymphoma (DLBCL NOS) patients (2L+ DLBCL) who are unsuitable for autologous hematopoietic stem cell transplantation (ASCT). Glofitamab (product name: Columvi) is a bispecific T-cell bridging protein targeting CD20 and CD3.

Gefitumab is a type of ready-to-use T-cell therapy that does not require customization. Relying on a novel 2:1 double antibody structure, it can simultaneously target 2 antigen molecules - CD3 antigen on the surface of T cells and CD20 antigen on the surface of B cells. While activating, amplifying, and redirecting T cells, it can bring stronger B-cell capture ability and efficacy, and enhance the ability to kill tumor cells under the premise of safe tolerance. Therefore, this treatment can help patients achieve early and deep relief and reduce the risk of disease progression.

In June 2023, the US FDA announced accelerated approval of Glofitamab for the treatment of adult patients with recurrent or refractory DLBCL or large B-cell lymphoma (LBCL) caused by follicular lymphoma, who have undergone second-line or multi-line systematic treatment (3L+DLBCL). The product was approved for marketing in China in November 2023 to treat adult patients with recurrent or refractory DLBCL who have received at least two previous lines of systematic treatment.