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Durvalumab granted breakthrough designation by FDA for locally advanced unresectable NSCLC

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for 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.

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 designation for durvalumab was granted on the basis of interim results from the Phase III PACIFIC trial, a randomised, 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.

Data from the PACIFIC trial have been submitted for presentation at a forthcoming medical meeting.

In May 2017, AstraZeneca received accelerated approval from the FDA for durvalumab 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.

Durvalumab is approved under the FDA’s accelerated approval pathway, based on tumour response rate and duration of response.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Source: BusinessWire



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