2nd Feb 2026 09:16
(Alliance News) - AstraZeneca PLC on Monday said Imfinzi, in combination with chemotherapy, has been recommended for approval in the EU for the treatment of adult patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers.
The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on event-free survival and overall survival data from the Matterhorn phase three trial, AstraZeneca said.
The trial showed a 29% reduction in the risk of progression, recurrence or death and a 22% reduction in the risk of death for the Imfinzi regimen versus chemotherapy alone.
"The CHMP recommendation marks further progress toward our goal to offer novel approaches in early-stage cancers where there is the greatest chance for cure and brings us closer to providing the third perioperative Imfinzi-based regimen in the EU," said Susan Galbraith, executive vice president for Oncology Haematology R&D at AstraZeneca.
Imfinzi is approved in the US and other countries in the same indication based on the Matterhorn results. Regulatory applications are currently under review in Japan and other countries.
In addition, the FTSE 100 listing said trading in its shares will begin on the New York Stock Exchange on Monday for the first time.
AstraZeneca said the trading of its shares is now aligned across the NYSE, the London Stock Exchange and Nasdaq Stockholm under a harmonised listing structure.
"This will allow even more investors to participate in AstraZeneca's future," commented Chair Michel Demare.
Last July, AstraZeneca pledged to invest USD50 billion in the US for medicines manufacturing and research & development.
In October, the Cambridge, England-based pharmaceuticals company struck a deal with the US government adopting a most-favoured-nation drug pricing model, designed to lower US costs to match the lowest in developed nations.
AstraZeneca also reached an agreement with the US Department of Commerce to delay Section 232 tariffs for three years, enabling it to fully onshore medicines manufacturing so that all of its medicines sold in the US are made in the US.
Shares in AstraZeneca were up 1.2% at 13,758.00 pence each in London on Monday morning. The wider FTSE 100 index was down 0.3%.
By Jeremy Cutler, Alliance News reporter
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