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AstraZeneca aims to deliver lung cancer drug Imfinzi to US 'as soon as possible'

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AstraZeneca has secured "breakthrough" therapy designation from US regulators for lung cancer drug Imfinzi

AstraZeneca has secured "breakthrough" therapy designation from US regulators for lung cancer drug Imfinzi

AstraZeneca has secured "breakthrough" therapy designation from US regulators for lung cancer drug Imfinzi

AstraZeneca hopes to bring American patients the lung cancer drug Imfinzi "as soon as possible" after securing "breakthrough" therapy designation from US regulators.

The move brings the drugs giant a step nearer to gaining regulatory approval following a successful "Pacific trial", which tested the treatment for patients with non-metastatic lung cancer

If it wins the full backing of the US Food and Drug Administration (FDA), it will then attempt to bring the drug to patients outside the US by seeking approval from regulators in Europe and other areas.

Imfinzi has already been approved for the treatment of bladder cancer.

Chief medical officer Sean Bohen said: "For patients who have not progressed following chemoradiation therapy, the only current option is active monitoring.

"Unfortunately, for the majority of patients, their cancer will progress to metastatic disease, typically within 12 months.

"Imfinzi is the first immuno-oncology medicine to show a clinically significant benefit in this earlier, non-metastatic setting, so following the Breakthrough Designation, we hope to bring it to patients as soon as possible."

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Shares rose more than 1.5% in morning trading on the London Stock Exchange, but failed to claw back Thursday's losses when the first round of the "Mystic trial" showed that a combination of durvalumab and tremelimumab does not improve lung cancer survival rates any more than chemotherapy.

The latest announcement comes amid speculation over the future of AstraZeneca chief executive Pascal Soriot, who has been linked with a move to Israeli firm Teva.

In an internal memo in July, Mr Soriot did not confirm or deny reports that he had accepted a job offer from the company.

The FTSE 100 firm revealed last week that half-year sales fell 11% to 10.5 billion US dollars (£7.9 billion) after the loss of patents on profitable drugs in the US.

Operating profit grew 37% to 1.8 billion US dollars (£1.3 billion).


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