US licence withdrawn for pembrolizumab for small-cell-lung cancer with disease progression on or after platinum-based chemotherapy and at least one other previous line of therapy

This use was previously authorised by FDA in June 2019 (never licensed in UK) via accelerated approval based on response data from 2 early studies, however confirmatory Phase III trial (KEYNOTE-604), didn’t reach statistical significance for primary endpoint of overall survival.

Biospace Inc.