FDA red and green lights: June 2025
Controversial nods came for Urogen’s Zusduri and Astra/Daiichi’s Datroway.
BeOne also needs B7-H4 biomarkers
The company’s BG-C9074 looks competitive, but there are questions about cutoffs and confirmed responses.
Better late than never for Datroway in lung cancer
Astra/Daiichi have trumped Gilead’s Trodelvy with a lung cancer approval.
Akeso looks early in small-cell lung cancer
A new phase 3 could see ivonescimab challenge AstraZeneca’s Imfinzi in limited-stage disease.
ASCO 2025 – Enhertu mounts its first-line charge
Enhertu plus Perjeta shows a convincing progression-free survival benefit over a Perjeta triplet.
ASCO 2025 – Astra seeks a new SERD paradigm
But camizestrant’s use could depend on uptake of monitoring – for now.
ASCO 2025 – vepdegestrant matches rival degraders
Any hopes of differentiation could come down to side effects.
ASCO 2025 – Trodelvy heads for the front line
Gilead’s TROP2 ADC sets the bar for Astra/Daiichi’s Datroway in first-line TNBC.
The month ahead: June’s upcoming events
Crunch time approaches for UroGen.
