FDA approves new drug Columvi for adults with hard-to-treat lymphoma.

The FDA has approved a new drug called Columvi (glofitamab) for adults with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL) that has come back or not responded to at least two prior treatments. This includes cases that started from follicular lymphoma. Columvi is a bispecific antibody that helps the immune system attack cancer cells. It is given by infusion into a vein using a step-up dosing schedule, and patients must first receive another drug (obinutuzumab) to reduce side effects. Because Columvi can cause a serious side effect called cytokine release syndrome (CRS), patients need to be hospitalized for the first dose and sometimes for later doses. This approval is under the FDA's accelerated pathway, meaning it is based on how well the drug shrinks tumors and how long that effect lasts. The company must still do more studies to confirm that Columvi helps patients live longer or feel better. If you or a loved one has DLBCL and has tried other treatments without success, talk to your doctor about whether Columvi might be an option. This approval offers hope for people who have few choices left, but it is important to understand the risks and benefits.