Roche wins FDA approval for bispecific lymphoma drug

June 16, 2023

The U.S. FDA has approved a bispecific antibody from Roche's Genentech to treat a type of advanced blood cancer, a month after AbbVie nabbed a similar approval.

Roche's Columvi, a CD20xCD3 bispecific, was approved to treat diffuse large B-cell lymphoma in adults who had received at least two prior lines of treatment before their cancer relapsed. The treatment was granted Accelerated Approval based on the phase 1/2 NP30179 study, which means continued approval is contingent on data from a confirmatory trial.

Back in May, the FDA approved a similar treatment from AbbVie and Genmab, branded Epkinly. Industry analysts think the drug has blockbuster potential, forecasting peak sales up to $2.75 billion. 

Roche, however, points to a key difference in the two drugs: Columvi has a fixed duration of treatment, administered in 13 intravenous infusions over a maximum of 12 cycles or until disease progression or the treatment cannot be tolerated, whichever occurs first. AbbVie's Epkinly needs to be administered until the disease progresses. According to Roche, Columvi offers patients a "target end date for their course of treatment and the possibility of a treatment-free period."

Columvi will be available in the U.S. in the coming weeks.