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# FDA Grants AstraZeneca ‘Breakthrough’ Status for Imfinzi
- URL: https://www.fdaweb.com/fda-grants-astrazeneca-breakthrough-status-for-imfinzi/
- Published: 2017-07-31T12:00:00.000Z
- Updated: 2026-09-14T22:37:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139254

FDA has granted AstraZeneca and MedImmune a breakthrough therapy designation for Imfinzi (durvalumab) for treating patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The designation was granted based on interim results from the [Phase III PACIFIC trial](https://www.astrazeneca.com/media-centre/press-releases/2017/imfinzi-significantly-reduces-the-risk-of-disease-worsening-or-death-in-the-phase-iii-pacific-trial-for-stage-iii-unresectable-lung-cancer-12052017.html?ref=fdaweb.com), a randomized, placebo-controlled multi-center trial of Imfinzi as sequential treatment in patients with locally-advanced, unresectable (Stage 3) NSCLC who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy. Recently, the agency granted accelerated approval for the therapy’s use in previously-treated patients with advanced bladder cancer.