The US Food and Drug Administration (FDA) has accepted Genentech’s Biologics License Application (BLA) for glofitamab, its experimental treatment for relapsed or refractory large B-cell lymphomas (LBCL), including diffuse large B-cell lymphoma (DLBCL), and granted it Priority Review.

The BLA, if approved, would allow glofitamab to be used for the treatment of adults with relapsed or refractory LBCL after 2 or more previous lines of systemic therapy. A decision from the FDA is expected by July 1, 2023.

Read more about DLBCL therapies

Glofitamab is a bispecific antibody designed to have one region that targets CD3 on the surface of T cells and 2 regions that target CD20 on the surface of B cells. The dual-targeting nature of glofitamab is engineered to cause the release of cancer-killing proteins from the T cells due to its close proximity to the potentially malignant B cells.

The application is based on data from the multicenter, open-label, phase 1/2 NP30179 study (NCT03075696). The study data showed that 62 out of 155 patients (40.0%) achieved complete response (CR) and 51.6% achieved an objective response (OR) after a median follow-up time of 13.4 months. The mean duration of response was 18.4 months.

Previous data from the study was published in the New England Journal of Medicine and showed that most patients who achieved CR at the end of treatment had durable responses with 61% of patients maintaining CR, 92.6% remaining progression-free, and 1 patient experiencing disease progression 12 months after ending treatment.

“Unfortunately, people with relapsed or refractory large B-cell lymphoma have a poor prognosis and desperately need additional therapies that are immediately available at the time of relapse,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech.

“Even for patients whose cancer is rapidly progressing, glofitamab given for a fixed duration has shown impressive efficacy and long-term durability, with patients continuing to experience a complete remission after treatment has concluded,” Garraway continued.

The most common adverse event reported during the study was cytokine release syndrome (CRS) which was generally reported only low-grade (grade 1 in 48.1% and grade 2 in 12.3% of patients). Most instances of CRS were associated with the initial administration of glofitamab. Only 3.9% of patients experienced grade 3 or higher CRS, with no patient experiencing a Grade 5 event. Only 1 of the 155 patients discontinued the use of glofitamab due to CRS.


FDA grants Priority Review to Genentech’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma. News release. January 6, 2023.