The FDA recently approved a new infused therapy, Columvi (glofitamab-gxbm) from Genentech, for the treatment of adult patients with 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. Columvi is a T-cell engaging bispecific antibody in non-Hodgkin’s lymphoma, joining recently approved Lunsumio indicated for follicular lymphoma.
DLBCL is considered hard to treat. It is the most common form of non-Hodgkin’s lymphoma. People with DLBCL who relapse and are refractory progress rapidly and have not been well served by prior therapies. The company pointed out that Columvi is “….an off-the-shelf, fixed-duration treatment providing durable response rates, we believe Columvi could change the way this aggressive lymphoma is treated.” “Further, Columvi offers “a chance for complete remission with a fixed-duration immunotherapy and that such remissions can potentially be sustained after the end of their treatment.”
The fixed-duration for Columvi, as detailed in the package insert, is 12 cycles at 21 day intervals.
Columvi was approved with a black box warning for Cytokine Release Syndrome.
The company said that the expected cost for Columvi will be about $350,000 for the full course and would be available in the United States in the coming weeks.
Distribution details were not disclosed. Given its cost and black box warning it is likely that product access will include specialty pharmacy distribution.
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FDA Approves Genentech’s Columvi for People with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Pivotal study showed durable responses, with a 56% overall response rate, a 43% complete response (remission) rate, and a median duration of response of 1.5 years (18.4 months)
Given over a fixed period of time, Columvi provides patients with a treatment end date and potential time off treatment.
South San Francisco, CA — June 15, 2023 –Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved Columvi® (glofitamab-gxbm) for the treatment of adult patients with 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 response rate and durability of response in the Phase I/II 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 United States in the coming weeks.
Patients with relapsed or refractory diffuse large B-cell lymphoma may experience rapid progression of their cancer ……………… press release continues
