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How RWE Was Used For Opdivo, Abecma & Orencia Approvals

 
• By Neena Brizmohun

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.

Doctors and medical researchers on conference meeting, discussing possible solutions for resolving a world health crisis.
It is important to be clear why RWE is being used • Source: Alamy

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).

There are various ways in which RWE might be used in a regulatory context from a sponsor perspective, noted Kalesnik-Orszulak, who is director, regulatory innovation lead for RWE & data...

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