- AstraZeneca and MedImmune, its global biologics research and development arm, have announced that the US Food and Drug Administration has granted breakthrough therapy designation for Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. Executive vice-president, global medicines development and chief medical officer at AstraZeneca, 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."

AstraZeneca said the breakthrough therapy designation was designed to expedite the development and regulatory review of new medicines that were intended to treat a serious condition and that had shown encouraging early clinical results, which demonstrated substantial improvement on a clinically-significant endpoint over available medicines and when there was significant unmet medical need.

At 9:17am:

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