Ensuring equitable access to targeted therapies: the regulatory perspective

In this video podcast, Dr. Justin Gainor and Dr. Sanjay Popat examine the evolving regulatory and clinical landscape of TRK inhibitors for NTRK fusion–positive NSCLC. They discuss the biology of oncogenic fusions, the evidence supporting current targeted therapies, and the challenges of developing and approving treatments for ultra‑rare molecular subsets. Their conversation highlights global differences in regulatory pathways, barriers to molecular testing, and the need for innovative trial designs and real‑world evidence to advance precision oncology.