AstraZeneca says the approval strengthens its push to bring immunotherapy earlier into cancer treatment, where long-term cures are possible
The decision follows compelling data from the AMPLIFY Phase III trial, demonstrating that 77% of patients receiving the Calquence-venetoclax combination were progression-free at three years
Each company will share operational data with Evinova, feeding the platform’s AI engines to provide benchmarks and actionable insights, aiming to speed up trials while maintaining top-tier patient care
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
CSPC will receive an upfront $1.2 billion from AstraZeneca for access to eight programmes, AI molecular design capabilities, and the LiquidGel platform
UK Prime Minister Keir Starmer praised the initiative, saying: “Unlocking opportunities for British businesses across the globe and delivering for working people back home is always the driving force behind my international engagements."
The move follows AstraZeneca’s previously announced plan to complete a direct listing of its Ordinary Shares and debt securities on the New York Stock Exchange
Appointment supports AstraZeneca’s $50 billion US investment and ambition to reach $80 billion in Total Revenue by 2030
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