Navigating the Glofitamab CRL and Bispecifics’ Place in Lymphoma

The landscape of lymphoma treatment is undergoing a radical shift, with novel immunotherapies paving the way for more targeted and effective care. Among these, bispecific antibodies stand out as an "off-the-shelf" option.

Tycel Phillips, MD, an associate professor in the Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation at City of Hope, to discuss the evolving role of bispecifics in the lymphoma space. Phillips offers his perspective on their current utilization, the challenges of accessibility, and the promise they hold for patients who may not be eligible for or interested in CAR T-cell therapy.

A complete response letter (CRL) from the FDA was recently given to the supplemental biologics license application (sBLA) for glofitamab-gxbm (Columvi) in combination with gemcitabine and oxaliplatin. The FDA determined that the data from the phase 3 STARGLO trial (NCT04408638) did not provide sufficient evidence to support a second-line indication for the proposed US patient population, particularly due to the small number of US patients enrolled in the global study.

Glofitamab retains its existing accelerated approval for heavily pretreated patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Transcript:

As of right now, in the NCCN, it’s a to-be designation, so you can, technically, in some cases, get it approved through insurance, but it’s not readily accessible to the bigger [population]. The problem we have is that outside of academic centers, there are not a ton of centers within the US, meaning community sites that are using bispecific antibodies, even the ones that are currently FDA approved. As of right now, it’s probably a niche treatment that’s most focused in academic sites, either with patients who they do not deem to be great candidates for CAR T-cell therapy, or patients who do not want to [receive] CAR T-cell therapy, or in some instances, as a treatment after patients relapse on CAR T-cell therapy. Hopefully, moving forward, as the bispecific antibodies get more integrated into the community setting, this will be something that could be utilized more readily across the various treatment centers within the US. The fact that it is an off-the-shelf treatment, it allows a little bit more accessibility for patients, vs having to relocate to a CAR T-cell center, which may not be close to their home. Then, given the efficacy that we have seen with the bispecific antibodies, you are getting comparable efficacy and durations of responses to what we have seen with some of the CAR T-cell products.

Reference

Genentech provides update on supplemental biologics license application for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma. News release. Genentech. July 21, 2025. Accessed August 21, 2025. https://tinyurl.com/4k5cs25n