Impressive overall survival data from the Phase III ADAURA trial should boost both EGFR testing in non-small cell lung cancer, and sales of the blockbuster NSCLC therapy.

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.

The US FDA gave the drug a broad label in adults with indolent SM, without restrictions for disease severity or prior treatment, and Blueprint sees a potential $1.5bn market opportunity.

Upcoming user fees include 16 novel agents, featuring two RSV vaccines, two gene therapies, and three oncologics. The Pink Sheet’s US FDA Performance Tracker breaks down the big month to come.