IMFINZI™ (durvalumab) Granted Breakthrough Therapy Designation By US FDA For Patients With Locally Advanced Unresectable Non-Small Cell Lung Cancer

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for IMFINZI™ (durvalumab), an anti-PD-L1 monoclonal antibody, being investigated 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.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, 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 Breakthrough Designation we hope to bring it to patients as soon as possible."

The Breakthrough Therapy Designation is designed to expedite the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically significant endpoint over available therapies and when there is significant unmet medical need. Use of durvalumab in patients with locally advanced, unresectable NSCLC is not yet FDA-approved.

The Breakthrough Therapy Designation for durvalumab was granted on the basis of interim results from the Phase III PACIFIC trial, a randomized, double-blinded, placebo-controlled multi-center trial of durvalumab as sequential treatment in patients with locally-advanced, unresectable (Stage III) NSCLC who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy. This achievement is the fourth Breakthrough Therapy Designation AstraZeneca has received from the FDA for medicines in Oncology over the past three years and the second for durvalumab. In May 2017, AstraZeneca received accelerated approval from the FDA for IMFINZI for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery. IMFINZI is approved under the FDA's accelerated approval pathway, based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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