AstraZeneca Hopes Imfinzi Breakthrough Get Can Burn Off MYSTIC Failure

Imfinzi becomes first cancer immunotherapy designated a breakthrough therapy for non-metastatic non-small cell lung cancer patients who have not progressed after platinum-based chemoradiation therapy, just days after announcing a missed primary endpoint in the first-line MYSTIC trial in metastatic NSCLC.

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A new breakthrough therapy designation (BTD) for AstraZeneca PLC's Imfinzi (durvalumab) signals FDA's confidence in the promise of the agent in non-metastatic non-small cell lung cancer, a setting earlier in the disease course than the metastatic NSCLC indications FDA has so far granted to immunotherapies.

The BTD is a welcome counterpoint to the disappointing results from the Phase III MYSTIC trial as first-line treatment for...

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