Bristol Myers: request for expanded indication for Breyanzi
(CercleFinance.com) - Bristol Myers Squibb has announced that the European Medicines Agency (EMA) has validated its application to extend the indication of Breyanzi to the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of treatment.
Validation of the application confirms that the dossier is complete and enables the scientific review to begin under the EMA's centralized review procedure.
Supported by data from a Phase II study, this application aims to offer a new treatment option for a cancer considered incurable and characterized by frequent relapses.
Breyanzi is already approved for other types of lymphoma in Europe and Japan.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
Validation of the application confirms that the dossier is complete and enables the scientific review to begin under the EMA's centralized review procedure.
Supported by data from a Phase II study, this application aims to offer a new treatment option for a cancer considered incurable and characterized by frequent relapses.
Breyanzi is already approved for other types of lymphoma in Europe and Japan.
Copyright (c) 2024 CercleFinance.com. All rights reserved.