Patient access pitfalls, regulatory inconsistencies hamper tissue agnostic drugs

At a Friday meeting FDA co-hosted with ASCO and Friends of Cancer Research, patient advocates expressed concern over their ability to access newly approved tissue-agnostic medicines, as well as clinical trials assessing up-and-coming treatments based on molecular markers rather than tissue of origin. Stakeholders also raised concerns about the lack of access to tumor-profiling technologies and inconsistent approaches among regulators to tissue-agnostic drug development.

At the workshop on the development of therapies for tissue agnostic, biomarker-based indications, patients talked about the difficulty of finding studies enrolling patients based on mutations and/or tumor molecular markers rather than tumor type...