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The FDA has granted for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), Genentech, the drug's developer, announced Thursday.

The approval covers patients with relapsed/refractory DLBCL not otherwise specified or large B-cell lymphoma caused by follicular lymphoma, after two or more lines of systemic therapy.

According to the company, glofitamab, a T cell-engaging bispecific antibody targeting CD20 and CD3, is the first bispecific antibody with a fixed-duration treatment for this patient population.

"Patients with relapsed or refractory diffuse large B-cell lymphoma may experience rapid progression of their cancer and often urgently need an effective treatment option that can be administered without delay," said Krish Patel, MD, director of the Lymphoma Program at the Swedish Cancer Institute in Seattle, in Genentech's press release.

"Experience from clinical trials demonstrates that Columvi can provide patients with relapsed or refractory diffuse large B-cell lymphoma a chance for complete remission with a fixed-duration immunotherapy and that such remissions can potentially be sustained after the end of their treatment," he added.

The approval was based on results from the , which was presented at last year's American Society of Hematology annual meeting and simultaneously published in the .

In that study, glofitamab was given as a fixed course for 8.5 months to 132 patients with relapsed or refractory DLBCL, 30% of whom had received prior chimeric antigen receptor (CAR) T-cell therapy, and 83% of whom were refractory to their most recent therapy.

Of these patients, 56% achieved an overall response, and 43% achieved a complete response, with more than two-thirds of patients continuing to respond for at least 9 months. The median duration of response was 1.5 years.

Among the patients who received glofitamab, the most common adverse event was cytokine release syndrome (70%), which was mostly low grade (grade 1: 52%; grade 2: 14%). Other common adverse events included musculoskeletal pain (21%), fatigue (20%), and rash (20%).

Glofitamab is administered in 13 intravenous infusions over a maximum of 12 cycles (including step-up dosing) or until disease progression or the treatment cannot be tolerated, whichever occurs first. After the first cycle, it is administered once every 3 weeks, and is designed to be completed in approximately 8.5 months. Patients are pretreated with a single dose of obinutuzumab (Gazyva) 7 days prior to starting glofitamab and also given a corticosteroid, an antipyretic, and an antihistamine as premedication to reduce the risk of cytokine release syndrome.

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