US FDA reviewers recommended against accelerated approval of Epizyme’s tazemetostat for epithelioid sarcoma, finding the modest overall response rates were not substantial evidence of an improvement over available therapies; they were overruled by senior oncology review staff, who cited a unanimous ODAC endorsement and the regulatory flexibility encouraged for rare diseases.

Following their original March 2019 tie-up for an oncology antibody-drug conjugate, Daiichi Sankyo and AstraZeneca have entered into a new global deal worth up to $6bn for a second novel asset from the Japanese firm, with potential in breast, lung and other cancers.

In this week's podcast edition of Five Must-Know Things: Biomarin’s next chapter; Amgen’s obesity plans; Daiichi’s new ADC data; Acelyrin hit by clinical failure; and Skyrizi beats Stelara in Crohn’s.