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AstraZeneca PLC on Friday said the US Food & Drug Administration has approved its cancer drugs Imfinzi and Imjudo in combination with chemotherapy for the treatment of adults with stage four non-small cell lung cancer.
The approval is based on Poseidon phase 3 data published in September 2021 and updated in September 2022. In September last year, Imfinzi and Imjudo plus chemotherapy showed an overall survival improvement of 23% in patients with stage IV non-small cancer compared to patients who merely received chemotherapy. This September, it showed a mildly higher survival improvement of 25%.
Meanwhile, AstraZeneca on Friday noted the availability of Soliris in China by its rare-disease focused group Alexion, a Boston, Massachussetts-based biopharmaceutical company it bought for $13.3 billion plus 236.3 million new AstraZeneca shares in July 2021.
Soliris is available in China for the treatment of paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome in adults in children. Paroxysmal nocturnal haemoglobinuria is a disease with which red blood cells break apart prematurely. Atypical haemolytic uraemic syndrome causes the formation of abnormal blood clots in small blood vessels in the kidneys, which can cause blood flow to be blocked or restricted.
"These milestones represent significant progress against our commitment to expand access to our rare disease medicines globally, including the introduction of innovative rare disease therapies in China," said Alexion Chief Executive officer Marc Dunoyer.
AstraZeneca shares fell 2.2% to 10,911.00 pence each in London on Friday morning.
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