Upcoming user fee goal dates include AstraZeneca’s tremelimumab, Amicus’ AT-GAA, and drug delivery technology-driven NDAs from Supernus/US Worldmeds and scPharmaceuticals

The era of follow-on medicinal chemistry has largely been eliminated by more comprehensive patent protection. Nowadays, investors trade on the differences in safety and efficacy for similar molecules.

A planned Phase II trial for PLK1 inhibitor onvansertib in KRAS-mutant colorectal cancer may support accelerated approval, but results are two years off and the company cut its prostate cancer plans to conserve cash.

In this week's podcast edition of Five Must-Know Things: a look ahead at potential oncology blockbuster approvals; strong data for Mirati’s KRAS contender in colorectal cancer; Keytruda’s architect reflects in its great success; Amgen’s waiting game for ChemoCentryx; and a look at dynamics in China’s sizzling immuno-oncology market.