Roche's Investigational Lymphoma Candidate Goes Under FDA Priority Review

The FDA has accepted Roche Holdings AG's RHHBY Biologics License Application (BLA) and granted priority review for glofitamab for relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
LBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and is one of the most prevalent types of blood cancer among adults in the U.S.
The FDA is expected to decide on the approval of this novel cancer immunotherapy by 1 July 2023.
Related: Roche Presents New Data Demonstrating Potential Benefit Of Two Lymphoma Candidates.
If approved, glofitamab would be the first fixed-duration, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody available to treat people with aggressive lymphoma who have previously received multiple courses of treatment.
The application is based on data from the pivotal Phase 1/2 NP30179 study. Results showed that 40.0% of patients (n=62/155) achieved a complete response (CR; a disappearance of all signs of cancer), and 51.6% (n=80/155) achieved an objective response (OR; the combination of CR and partial response, a decrease in the amount of cancer in their body).
The median follow-up time was 13.4 months. Among those who achieved a CR, 73.1% continued to experience a response at 12 months, while the median duration of CR was not reached. The median duration of response was 18.4 months.