Roche Submits New Indication Application for Glofitamab in China

Sep 05, 2024 11:07 CST Updated 11:07

Roche

Oncology Drug Research, Development, and Manufacturing

On September 5, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration announced on its official website that it had accepted Roche's marketing application for a new indication of Gazyva (Obinutuzumab) Injection. Although the specific indication has not been disclosed, based on information from Roche’s official website and existing public data, it can be speculated that the new indication may involve the combination use of gemcitabine and oxaliplatin for treating patients with diffuse large B-cell lymphoma (2L+ DLBCL) who are ineligible for autologous stem cell transplantation.

Gefitumab is a bispecific antibody that can simultaneously target CD20 and CD3. As a T-cell engager, it is able to recruit T cells to the vicinity of CD20-expressing B cells, thereby enhancing the immune response against tumor cells.

If this new indication is approved, it will provide a new treatment option for patients with diffuse large B-cell lymphoma, especially for those who are not suitable for autologous stem cell transplantation. This will also once again demonstrate Roche's R&D strength and innovation capabilities in the field of hematological oncology. As the review process progresses, we look forward to more detailed information and evaluation results regarding the new indication for Glevituximab.

Glofitamab (Mosunetuzumab)'s unique 2:1 structure gives it a potential advantage in treating certain types of B-cell non-Hodgkin lymphoma (NHL). This bispecific antibody consists of two protein domains that bind to CD20 and one protein domain that binds to CD3, which can directly guide T cells to the vicinity of CD20-expressing B cells, activating T cells and releasing cytotoxic proteins to attack cancer cells.

In June 2023, the U.S. FDA granted accelerated approval to glofitamab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least two or more lines of systemic therapy.

In November 2023, Glofitamab was approved for marketing in China, for the treatment of adult patients with relapsed or refractory DLBCL who have previously received at least two lines of systemic therapy.

At the European Hematology Association (EHA) conference in June 2023, Roche announced detailed results from the Phase 3 STARGLO trial. These results showed that, compared to the active control drug, treatment with glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) demonstrated better efficacy in patients with relapsed or refractory DLBCL, including longer median overall survival (OS), longer median progression-free survival (PFS), and a higher complete response (CR) rate.

Roche's official website shows that glofitamab has several indications in Phase 3 clinical stage, including first-line treatment of DLBCL in combination with Polivy (polatuzumab vedotin) and R-CHP (rituximab, cyclophosphamide, doxorubicin, prednisone), as well as the treatment of relapsed or refractory mantle cell lymphoma (MCL).

According to the official website of the China Drug Clinical Trial and Information Disclosure Platform, Roche has launched a Phase 3 clinical trial in China to evaluate the efficacy and safety of glofitamab monotherapy versus investigator's choice of treatment in patients with relapsed/refractory mantle cell lymphoma.

These advances indicate that glofitamab has significant potential in treating certain types of B-cell lymphoma, and Roche is actively advancing its clinical development and market access worldwide. As more clinical data is released and regulatory reviews progress, we look forward to glofitamab offering new treatment options for more patients.

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