Xpovio's US FDA Review: A Primer On How (Not) To Submit Real-World Data

Real-world data (RWD) is still in its infancy at the US Food and Drug Administration, and sponsors are trying to navigate the landscape of how such data can support their drug applications. An inside look at an RWD study by Karyopharm Therapeutics Inc. to support the accelerated approval for its multiple myeloma drug Xpovio provides a cautionary tale on what not to do.