Main study: Viale-A Main drivers of decision: The decision of considerable added benefit for the indication in the original dossier assessment A21-82 was unchanged. The company presented subsequent evaluations for the morbidity endpoint transfusion independence based on event-time analyses. The subsequent analyses demonstrated an advantage of combined venetoclax for the endpoint transfusion independence, however, the data raised uncertainties with regards to validity of results and the operationalisation of the endpoint.