Small team, major impact: behind the scenes of an EMA application

On September 17, it was announced that the EMA’s scientific committee, the CHMP, had issued a positive opinion on expanding the indication for Oncopeptides’ multiple myeloma drug to earlier lines of treatment. The change means that the requirement for patients to be triple-class refractory will be removed.
In this episode, we meet Mette Palm, Head of Regulatory Affairs at Oncopeptides. She explains how she and her colleague Maja prepared, in a short period of time, an application that prompted just one question from the regulatory authority. We also discuss why the company previously chose to focus on later lines of treatment, what has changed since then, and the steps that remain before the European Commission makes its final decision.

Podcast in Swedish only, follow this link for transcripts in Swedish and English:
https://oncopeptalks.com