Feb. 13, 2025 -- The FDA has approved a new three-drug combination to treat certain types of an aggressive blood cancer called large B-cell lymphoma (LBCL).
The treatment combines a medicine called brentuximab vedotin with the standard drugs lenalidomide and rituximab, individually approved by the FDA in 2011, 2005, and 1997, respectively. It is intended for adults in whom the cancer has returned or didn’t respond to two or more prior therapies and who can’t undergo a stem cell transplant or CAR T-cell therapy.
LBCL is a fast-growing cancer of B cells, a type of white blood cell crucial for the immune system. It’s usually diagnosed in older adults at advanced stages. The most aggressive form, diffuse large B-cell lymphoma (DLBCL), makes up over 25% of lymphoma cases in the United States. Many patients relapse or don’t get help from standard treatments, highlighting the need for better treatment options.
Brentuximab vedotin (Adcetris), made by Seagen (a Pfizer subsidiary), delivers chemotherapy to tumor cells. Rituximab targets and destroys cancerous B cells, while lenalidomide strengthens the immune system and slows cancer spread. Combined, they provide a new treatment for LBCL, including DLBCL and high-grade B-cell lymphoma.
The FDA approval was based on a clinical trial involving 230 patients with relapsed or nonresponsive LBCL who couldn’t receive advanced treatments. Patients received either Adcetris with lenalidomide and rituximab or a placebo with lenalidomide and rituximab. Results showed the new treatment helped patients live longer (13.8 months vs. 8.5 months), delayed cancer progression (4.2 months vs. 2.6 months), and had a higher response rate (64.3% vs. 41.5%) compared to the placebo combo.
Common side effects include tiredness, diarrhea, nerve pain or numbness, skin rash, pneumonia, COVID-19 infection, and low hemoglobin levels and blood cell counts. The safety of Adcetris was consistent with that found in previous studies, with no new concerns identified, according to a news release by Pfizer.
Patients taking Adcetris should report any nerve pain, burning sensation, numbness, or weakness to their doctor immediately. They must inform their doctor of any heart, liver, kidney, or neurological issues before starting treatment. As Adcetris may harm an unborn baby, women should take a pregnancy test before starting treatment and use birth control during treatment and for two months after the last dose. Men should use contraception during treatment and for four months after the last dose.
