
Bristol Myers: application validated in follicular lymphoma
(CercleFinance.com) - Bristol Myers Squibb announces that the European Medicines Agency (EMA) has validated its application for a type II variation to extend the indication for Breyanzi, a chimeric antigen receptor (CAR) T-cell therapy directed against CD19.
This application would enable the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior lines of systemic therapy.
It is supported by data from the Phase 2 TRANSCEND FL study, in which Breyanzi demonstrated profound and durable responses, as well as a consistent and well-established safety profile, the pharma group says.
Validation of the application confirms that the submission is complete, and allows scientific review to begin under the centralized review procedure by the European Union's health authority.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
This application would enable the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior lines of systemic therapy.
It is supported by data from the Phase 2 TRANSCEND FL study, in which Breyanzi demonstrated profound and durable responses, as well as a consistent and well-established safety profile, the pharma group says.
Validation of the application confirms that the submission is complete, and allows scientific review to begin under the centralized review procedure by the European Union's health authority.
Copyright (c) 2024 CercleFinance.com. All rights reserved.