The US Food and Drug Administration approved glofitamab (Columvi®) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and large B-cell lymphoma arising from follicular lymphoma.
The treatment is expected to be available in the United States very soon.
Read more about DLBCL experimental therapies
“People with diffuse large B-cell lymphoma who have gone through multiple lines of therapy have a poor prognosis and desperately need additional treatment options,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, the developers of the treatment, in a press release.
“As an off-the-shelf, fixed-duration treatment providing durable response rates, we believe glofitamab could change the way this aggressive lymphoma is treated, reinforcing our dedication to bringing innovative treatment options to people with critical unmet needs,” Dr. Garraway continued.
The approval is based on results from a phase ½ trial that evaluated the efficacy, safety, pharmacokinetics, and tolerability of glofitamab. During the trial, 132 participants with relapsed or refractory DLBCL after 2 prior therapies were treated with glofitamab for a fixed duration of 8.5 months. This led to durable remission, with more than half of patients achieving an overall response and almost half reaching a complete response.
The most common adverse events associated with the treatment were fatigue, cytokine release syndrome, musculoskeletal pain, and rash (20%).
“Experience from clinical trials demonstrates that glofitamab can provide patients with relapsed or refractory diffuse large B-cell lymphoma a chance for complete remission with a fixed-duration immunotherapy and that such remissions can potentially be sustained after the end of their treatment,” said Krish Patel, MD, the director of the lymphoma program at the Swedish Cancer Institute in Seattle and an investigator in the phase 1/2 study.
Glofitamab is a CD20xCD3 T-cell engaging bispecific antibody which targets both T- and B cells. It has 1 region that binds to CD3 on T-cells and 2 regions that bind to CD20 on B-cells. This brings the T- and B-cells close together and activates the release of cancer cell-killing proteins from the T-cells resulting in B-cell death.
FDA approves Genentech’s Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma. News release. Genetech. June 15, 2023.
A dose escalation study of glofitamab (RO7082859) as a single agent and in combination with obinutuzumab, administered after a fixed, single pre-treatment dose of obinutuzumab in participants with relapsed/refractory B-cell non-Hodgkin’s lymphoma. US National Library of Medicine. Updated May 16, 2023. Accessed July 21, 2023.