FDA Sets Goal Date for Lymphoma Drug Columvi

Genentech announced the FDA acceptance of a supplemental biologics application (sBLA) for Columvi (glofitamab-gxbm) to be used in combination with gemcitabine and oxaliplatin (GemOx), according to the details of a recent news release. If approved, this regimen will be used as a second-line treatment for relapsed, or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in patients who are not candidates for an autologous stem cell transplant and have received one prior line of therapy. The FDA’s decision is expected by July 20, 2025.

This sBLA is based on the results of the ongoing phase 3 STARGLO study, recently published in The Lancet. Patients treated with Columvi plus GemOx had a 41% reduction in death risk, when compared with patients treated with a combination of Rituxan(rituximab) and GemOx. The median overall survival of patients treated with Columvi was 25.5 months, whereas patients treated with R-GemOx had a median survival rate of 12.9 months, according to the study. Columvi also met its key secondary endpoints, achieving a 63% reduction in risk of disease worsening, reported by the company in July.

“For people with aggressive lymphomas like DLBCL, timely intervention with effective therapies can be crucial to reduce the risk of disease progression and improve long-term outcomes,” Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development, said in a news release. “We are encouraged by the overall survival benefit seen with this Columvi combination and hope it can become an important treatment option for those who are in need of alternative therapies.”

One of the most common adverse effects was an increased risk of cytokine release syndrome (CRS), which occurs when the immune system responds more aggressively than it should to an infection or immunotherapy, causing fever, chills and in extreme cases, death. Cases observed were generally low grade with 31.4% Grade 1, 10.5%, Grade 2: and 2.3% Grade 3.

Due to the risk of cytokine release syndrome, Columvi will be given on a step-up dosing schedule. There are 12 treatment cycles divided into 21 days.

The current price of Columvi is $2,780 for a supply of 2.5 mL, according to Drugs.com. Patients without insurance can visit Genentech Patient Foundation. Patients with private insurance can find help through the Genentech Oncology Co-pay Assistance Program, where up to $25,000 in co-pay assistance is available every calendar year.