The U.S. Food and Drug Administration (FDA) granted priority review to glofitamab for the treatment of relapsed or refractory (R/R) large B-cell lymphoma (LBCL) in adults. Glofitamab is an investigational CD20×CD3 T-cell engaging bispecific antibody.
Priority review was granted based on data from the phase I/II NP30179 study. Patients had two or more prior lines of therapy. Results of the study found complete response (CR) in 40% of patients, objective response in 51.6% of patients, and a median response duration of 18.4 months.
Additionally, a year after treatment with glofitamab, 92.6% of patients remained progression free and 61% maintained CR.
“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,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development.
Glofitamab is being evaluated in several studies in combination with other drugs and as a monotherapy, including the phase III STARGLO trial, which is evaluating glofitamab in combination with gemcitabine and oxaliplatin.
The FDA’s approval decision is expected by July 1, 2023.
Source: Roche, January 6, 2023.