In an editorial published this month on the Lancet Oncology, the authors relate to the FDA’s May 2017 accelerated approval for Pembrolizumab to treat adults and children with unresectable or metastatic solid tumours with high microsatellite instability (MSI-H) or mismatch-repair deficiency (dMMR), which is the first time any regulatory agency has approved a cancer drug on the basis of a molecular target rather than on the tissue of origin. This action represents a major shift in thinking by the FDA, and anticipates a potential transformation in the way clinical trials are designed and oncology is routinely practiced.
Precision medicine is indeed embraced by oncologists in growing numbers, however, even in the US it remains mainly practiced in research driven medical centers. This decision may be the beginning of a new era that will encourage more hospitals to adopt fully integrated precision oncology services and highlights the importance of companies that provide molecular diagnostics that are integrated into the clinicians workflow and result in improved time and costs.
Read the full article at: http://www.thelancet.com/action/showFullTextImages?pii=S1470-2045%2817%2930474-6