Genentech has shared important insights regarding its application for Columvi, a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The FDA’s Oncologic Drugs Advisory Committee (ODAC) recently discussed the drug’s supplemental application, focusing on its effectiveness when combined with GemOx. The results of the Phase III STARGLO study, which included diverse international patients, reveal that the Columvi combination offers significant survival benefits.
Key Points
- Columvi, the first bispecific antibody for DLBCL, showed a 41% reduction in death risk during the Phase III STARGLO trial.
- This combination therapy addresses a pressing need for effective options, particularly for patients ineligible for stem cell transplants.
- The clinical trial’s population mirrors the U.S. DLBCL patients, suggesting the findings are highly applicable.
- The FDA is still reviewing the Columvi application, with a decision expected by July 20, 2025.
- Columvi combined with GemOx is already approved in over 30 countries, including the EU.
Why should I read this?
If you’re interested in the latest cancer treatments, this update on Columvi is a must-read! It dives into how this new therapy could really shake things up for patients with DLBCL, especially those who don’t have many options. With survival rates on the rise, it’s a piece of news that could make a tangible difference in treatment pathways.