Roche's Bispecific Antibody With Fixed-Duration Treatment Scores FDA Approval For Type Of Lymphoma

The FDA approved Roche Holding AG's RHHBY Columvi (glofitamab-gxbm) for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. 

This indication is approved under accelerated approval based on the response rate and durability of response in the phase 1/2 NP30179 study. 

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Columvi will be available in the US in the coming weeks. 

The FDA accelerated approval is based on phase 1/2 NP30179 study results. 

Results showed that patients treated with fixed-duration Columvi achieved durable remission, with 56% of patients achieving an overall response and 43% achieving a complete response.

Over two-thirds of those who responded continued to respond for at least nine months (68.5%). 

The median duration of response was 1.5 years.

Columvi is the first and only CD20xCD3 T-cell engaging bispecific antibody for the treatment of R/R DLBCL that is given for a defined time, unlike treat-to-progression approaches where treatment is given indefinitely until cancer progresses or the therapy cannot be tolerated, whichever occurs first.