Roche gains accelerated approval from the FDA for latest cancer therapy

Considering a recent Phase II trial, the FDA have granted accelerated approval to Roche and Genentech for their bispecfic therapeutic for the treatment of types of lymphoma. 

Columvi, otherwise known as glofitamab, is a bispecific therapy used to treat large B-cell lymphoma, more specifically it is suitable for use in adults with diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that either has relapsed, hasn’t responded to other lines of therapy, or in patients who have had 2 or more treatment options already. 

The approval falls under the FDA’s accelerated approval programme, and was granted very quickly, even with a shorter priority review timeline. This brings the treatment up level with Epkinly from AbbVie and Genmab, the other CD20xCD3 bispecific T-cell engager on the market. 

The approval comes after showing good consistent results in a Phase II clinical trial, however, unlike Epkinly, the drug from Roche doesn’t address potential treatment of high-grade B-cell lymphoma, even though patients with this presentation made up 7% of the trial subjects. Even so, DLBCL represented the larger cohort and was a main focus of the study. 

The treatment is administered currently as an intravenous infusion, which is less accessible than Epkinly, which can be given as a subcutaneous injection, but Roche are working on a formulation that could be administered subcutaneously to elevate the treatment and rival Abbvie/Genmab’s drug. 

To Ginna Laport, Genentech’s Global Head of Lymphoma and Chronic Lymphocytic Leukaemia Development, Columvi’s biggest differentiator and distinct advantage is its fixed duration for treatment.

Laport stated that compared to the usual approach of treatment until a cessation of progression, this programme “allows patients for treatment-free interval, [and] it decreases the chance of long-term side effects,” in an interview from the American Society of Clinical Oncology Annual Meeting.