South San Francisco, CA — May 7th, 2025 —
Genentech will participate in the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) meeting on May 20, 2025 regarding the supplemental Biologics License Application (sBLA) for Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant (ASCT).
The sBLA is based on data from the Phase III STARGLO study, a multicenter, open label, randomized clinical trial, which showed a 41% reduction in the risk of death (hazard ratio [HR]=0.59, 95% CI: 0.40–0.89, p=0.011) versus MabThera®/Rituxan® (rituximab) plus GemOx in patients treated with Columvi in combination with GemOx. The Columvi combination also met its key secondary endpoints, with a 63% reduction in risk of disease worsening or death (progression-free survival, PFS) compared to R-GemOx (HR=0.37; 95% CI: 0.25–0.55, p<0.0001). A follow-up analysis conducted after all patients had completed therapy (median follow-up of 20.7 months), showed continued benefit in both primary and secondary endpoints. Median OS for people treated with the Columvi combination was 25.5 months, nearly double what was seen for people treated with R-GemOx at 12.9 months (HR=0.62, 95% CI: 0.43-0.88). Safety of the combination appeared consistent with the known safety profiles of the individual medicines.*
We look forward to continued collaboration with the FDA and discussions with the advisory committee to support the application process. The FDA PDUFA date for this application is July 20, 2025.
STARGLO is the first randomized Phase III study in patients with transplant-ineligible R/R DLBCL to meet its primary endpoint of improving OS, demonstrating the potential of this Columvi combination to improve survival outcomes in earlier lines of treatment. Based on data from the STARGLO study, regulatory submissions for Columvi plus GemOx for the treatment of patients with R/R DLBCL are ongoing around the world. In April 2025, the European Commission approved this Columvi combination for the treatment of adult patients with R/R DLBCL not otherwise specified who are ineligible for ASCT.
The need for additional, effective treatment options has been acknowledged by the National Comprehensive Cancer Network® (NCCN®), which has recently added glofitamab-gxbm (Columvi) in combination with GemOx to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as an NCCN category 1 preferred recommendation for the treatment of people with second-line DLBCL who have relapsed late (>12 months) and are not intended to proceed to transplant, and a category 2A preferred recommendation for those who have relapsed early (<12 months) or have primary refractory disease and are not candidates for CAR T.†
*Adverse event (AE) rates were higher with the Columvi combination versus R-GemOx, noting higher median number of cycles received with Columvi combination (11 versus 4). One of the most common AEs was cytokine release syndrome, which was generally low grade (Any Grade: 44.2%, Grade 1: 31.4%, Grade 2: 10.5%, Grade 3: 2.3%) and occurred primarily in Cycle 1.
†NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Columvi, an off-the-shelf, fixed-duration bispecific antibody, received accelerated approval by the U.S. Food and Drug Administration on June 15, 2023 as a monotherapy to treat people with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy based on the pivotal Phase I/II NP30179 study. Columvi is currently approved for the third-line indication in over 60 countries and around 6,000 patients, including nearly 2,000 in the U.S., have been treated globally to date.
Diffuse large B-cell lymphoma (DLBCL) is an aggressive disease and is the most common form of non-Hodgkin lymphoma in the U.S. Approximately four out of ten patients will relapse after first-line treatment and the majority of patients who require subsequent lines of therapy have poor outcomes. While second-line treatment advances have been made, challenges with the accessibility of existing medicines and the aggressive nature of DLBCL underscores the urgent need for immediately available treatment options that may be able to control the disease and improve survival.
Columvi (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer.
It is not known if Columvi is safe and effective in children.
The conditional approval of Columvi is based on response rate and durability of response. There are ongoing studies to establish how well the drug works.
What is the most important information I should know about Columvi?
Columvi can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Columvi, and can also be serious and lead to death.
Call your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of CRS, including:
Due to the risk of CRS, you will receive Columvi on a “step-up dosing schedule”.
Your healthcare provider will monitor you for CRS during treatment with Columvi and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Columvi if you have severe side effects.
Carry the Columvi Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Columvi Patient Wallet Card lists the signs and symptoms of CRS you should get emergency medical help for right away.
What are the possible side effects of Columvi?
Columvi may cause serious side effects, including:
The most common side effects of Columvi include: CRS, muscle and bone pain, rash, and tiredness.
The most common severe abnormal lab test results with Columvi include: decreased white blood cells, decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting).
Your healthcare provider may temporarily stop or completely stop treatment with Columvi if you develop certain side effects.
Before receiving Columvi, tell your healthcare provider about all of your medical conditions, including if you:
Females who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What should I avoid while receiving Columvi?
Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems.
These are not all the possible side effects of Columvi. Talk to your health care provider for more information about the benefits and risks of Columvi.
You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see Important Safety Information, including Serious Side Effects, as well as the Columvi full Prescribing Information and Medication Guide or visit https://www.Columvi.com
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.