Unraveling innovation potential in the real-world setting; eighteen novel agents with twenty-six approved European indications, in the management of leukemias, lymphomas and multiple myeloma.

Unraveling innovation potential in the real-world setting; eighteen novel agents with twenty-six approved European indications, in the management of leukemias, lymphomas and multiple myeloma. Expert Rev Hematol. 2019 Sep 14;: Authors: Petrakis I, Kontogiorgis C, Nena E, Athanasakis K, Gougoula V, Kotsianidis I, Constantinidis TC Abstract Introduction: Real-world effectiveness of hemato-oncology pharmaceuticals may not necessarily mimic clinical trial efficacy results, mainly due to demographic and clinical practice variability. The aim of this review was to systematically assess the availability of real-world evidence (RWE) and the transferability of clinical trial (CT) efficacy results to real life, for novel agents recently approved to manage lymphomas, leukemias and multiple myeloma. This is the largest cross-indication review comparing RWE to CT results, aspiring to inform clinical practice and decision making when funding hemato-oncology pharmaceuticals. Areas Covered: The review methodology focused on identifying all novel agents that entered EU landscape between 2012 and 2016 by using European Medicines Agency (EMA) database, while conducting a systematic PubMed literature review of RWE in the specific hematological malignancies, in order to compare RWE versus CT efficacy endpoints. Expert Opinion: In total, 18 international non-proprietary names (INNs) that received EMA approval for any indication were included and the regist...
Source: Expert Review of Hematology - Category: Hematology Tags: Expert Rev Hematol Source Type: research