Roche Announces NMPA Approval of Glofitamab New Indication in China for Relapsed/Refractory DLBCL

On May 7, Roche announcedGefitumabMonoclonal Antibody InjectionThe new indication marketing application has been approved by the China National Medical Products Administration (NMPA).Combination of Gemcitabine and Oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified (DLBCL NOS), who are ineligible for autologous hematopoietic stem cell transplantation (ASCT) (2L+ DLBCL)Glofitamab is aBispecific T-cell engager targeting CD20 and CD3. This product was approved for the first time in China in November 2023 and is used forTreatment of adult patients with relapsed or refractory DLBCL who have received at least two prior lines of systemic therapy。

According to the STARGLO study results, patients receiving gefitumab combination therapy achieved nearly double the median overall survival (OS), with a median OS of 25.5 months (12.9 months in the R-GemOx group); the median progression-free survival (PFS) increased nearly fourfold (13.8 months vs. 3.6 months), and the overall response rate (ORR) and complete response (CR) rate improved by 27.7% and 33.2%, respectively, compared to the control group. Additionally, the safety profile of gefitumab combination therapy was favorable, with more patients completing the full treatment cycle.

Gefitumab is a type of non-customizableReady-to-use T-cell therapyBy simultaneously binding to CD20 on the surface of B cells and CD3 on the surface of T cells, it mediates the formation of immune synapses, subsequently triggering T-cell activation and proliferation, cytokine secretion, and release of cytolytic proteins, thereby inducing the lysis of CD20-expressing B cells and enhancing the ability to kill tumor cells under safe and tolerable conditions.

In June 2023, the U.S. FDA announced the accelerated approval of glofitamab for the treatment of adult patients with relapsed or refractory DLBCL or large B-cell lymphoma (LBCL) caused by follicular lymphoma, who have undergone second-line or multiple lines of systemic therapy (3L+ DLBCL).Gefitumab is the firstFor patients with relapsed or refractory diffuse large B-cell lymphomaFixed-Course Treatment with Bispecific Antibodies。

GefitumabApproved by the FDAThe SecondBispecific antibody specifically for DLBCL, AbbVie'sEpkinly is the firstThe subcutaneously injectable T-cell engaging bispecific antibody approved by the FDA for treating such patients is also the first bispecific antibody approved for treating R/R FL and R/R diffuse large B-cell lymphoma (DLBCL) patients who have received at least two prior therapies. It received accelerated FDA approval in May 2023. Epkinly is administered subcutaneously and was listed by the industry media Evaluate as...One of the Top 10 Potential Blockbuster Therapies of 2023。

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