- Genentech receives a Complete Response Letter (CRL) from the FDA regarding its supplemental Biologics License Application for Columvi combination therapy.
- Columvi remains under accelerated approval in the U.S. for third-line or later treatment of diffuse large B-cell lymphoma (DLBCL).
- STARGLO study results show a 41% reduction in risk of death for Columvi and GemOx combination, but further FDA discussions are ongoing.
Genentech, a member of the Roche Group, has announced that the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its supplemental Biologics License Application (sBLA). This application sought approval for the use of Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) as a treatment option for individuals with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are unsuitable candidates for autologous stem cell transplants.
The FDA's decision indicates that the STARGLO study data do not sufficiently support the proposed indication for second-line DLBCL treatment within the U.S. population. Columvi, however, continues to be available under accelerated approval for third-line or later DLBCL treatment in the United States.
The CRL comes despite positive data from the Phase III STARGLO study, which demonstrated a statistically significant 41% reduction in the risk of death (hazard ratio=0.59, p=0.011) for patients treated with the Columvi and GemOx combination. While the combination therapy has gained approval in over 35 countries, including the European Union, discussions with the FDA are ongoing to verify the potential of the Phase III SKYGLO study.
According to Genentech, they remain committed to exploring Columvi's potential in various treatment settings, including as a frontline therapy option. Genentech also emphasizes its dedication to elevating treatment standards in early-stage DLBCL to improve long-term patient outcomes.
