Posted on about 1 year ago by Laurentina Kennedy
Roche follows AbbVie with FDA approval for dual-targeting lymphoma drug
Dive Brief:
The Food and Drug Administration has approved a new medicine for a tough-to-treat blood cancer, clearing Roche’s Columvi for use in certain patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL.
The drug, an antibody also called glofitamab, is for use in DLBCL patients who have previously received two or more lines of systemic therapy. The clearance is “accelerated,” meaning Roche must confirm the drug’s benefit in follow-up testing.
Columvi is the second “bispecific antibody” approved for DLBCL since May, when the FDA gave an OK to AbbVie and Genmab’s Epkinly. The decision was based on data from a Phase 1/2 trial, updated results from which were published in the
New England Journal of Medicine last December. In that study, 56% of patients responded to treatment and 43% went into remission. Responses lasted for a median of one and a half years.
Dive Insight:
Bispecific antibodies like Columvi are dual targeting, designed to bind to two cellular proteins, rather than one. In recent years, these types of drugs have won approval for use in multiple types of tumors, eye diseases and hemophilia.
Development has been fastest in blood cancer, where bispecifics are often made to latch onto proteins found on cancer cells with one arm, while hooking immune cell proteins with the other. In some cases, they’re seen as more accessible alternatives to CAR-T cell therapies.
In an editorial published alongside Columvi’s results in December, Nancy Bartlett, an oncology professor at the Washington University School of Medicine, noted the remission rates in testing rivaled the durable responses seen with CAR-T in large B-cell lymphoma. While questions about their potential remain, bispecifics “will be an excellent option” for those who don’t respond to second-line CAR-T treatment and potentially “considered as the initial choice for second- or third-line care,” she wrote.
Developers are targeting other cancers, too. Roche brought the first bispecific for follicular lymphoma, Lunsumio, to market last year. The FDA approved another, Johnson & Johnson’s multiple myeloma medicine Tecvayli, in 2022. Behind those are several similar medicines from companies like Pfizer, Regeneron Pharmaceuticals and Bristol Myers Squibb.
Columbi’s approval highlights the growing competition. It follows Epkinly, a medicine that, like Columvi, binds to one protein named CD20 and another on T cells called CD3.
Upon Epkinly’s approval, AbbVie and Genmab called their drug the “first and only” bispecific for adults with relapsed and refractory DLBCL. Roche responded in its statement by declaring Columvi the “first and only bispecifc antibody with a fixed-duration treatment,” referencing how its given for only a specific period of time.
As with other medicines of its kind, treatment is commonly associated with a type of immune reaction called cytokine release syndrome that, in testing, was generally mild to moderate in severity.
The drug is expected to be available in the U.S. in the coming weeks.
Editor’s note: This story has been updated to clarify the results the FDA based its decision on.