Roche: FDA accepts Columvi's review in lymphoma
(CercleFinance.com) - Roche announced on Thursday that the FDA had accepted for review the registration application for its Columvi antibody in the treatment of relapsed or refractory diffuse large B-cell lymphoma.
The application covers the combination of Columvi with gemcitabine and oxaliplatin chemotherapy in previously treated patients ineligible for stem cell transplantation.
Roche says that its application is based on the results of a Phase III study showing a statistically significant and clinically relevant improvement in patients' overall survival compared to the administration of MabThera/Rituxan in addition to chemotherapy.
Columvi is a humanized bispecific monoclonal antibody that binds to lymphocytes, thereby activating the cancer-killing proteins present in T-cells.
The FDA's decision expected by 20 July 2025.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
The application covers the combination of Columvi with gemcitabine and oxaliplatin chemotherapy in previously treated patients ineligible for stem cell transplantation.
Roche says that its application is based on the results of a Phase III study showing a statistically significant and clinically relevant improvement in patients' overall survival compared to the administration of MabThera/Rituxan in addition to chemotherapy.
Columvi is a humanized bispecific monoclonal antibody that binds to lymphocytes, thereby activating the cancer-killing proteins present in T-cells.
The FDA's decision expected by 20 July 2025.
Copyright (c) 2024 CercleFinance.com. All rights reserved.