The use of real-world evidence (RWE) is increasingly being used to support regulatory decisions when it comes to the approval of new medicines or extended indications. Knowing when to use RWE in regulatory submissions is key, according to Bristol Myers Squibb’s Rob Kalesnik-Orszulak, who shared his company’s experiences with using RWE in marketing applications for three BMS products – Opdivo (nivolumab), Abecma (idecabtagene vicleucel/ide-cel) and Orencia (abatacept).
How RWE Was Used For Opdivo, Abecma & Orencia Approvals
Bristol Myers Squibb’s use of real-world evidence in US and EU marketing applications for three of its products shows how population bridging, external controls and comparative effectiveness might be employed.
