Partial hold on AstraZeneca cancer drug trial lifted by FDA

22 November 2016
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There was good news for AstraZeneca (LSE: AZN), with US regulators giving the green light for the Anglo-Swedish pharma major to restart recruitment in two clinical trials of one of its most important cancer drug candidates.

The US Food and Drug Administration has lifted the partial clinical hold on the enrolment of new patients with head and neck squamous cell carcinoma (HNSCC) for clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential medicines.

The Phase III KESTREL trial has already re-opened for new patient enrolment at some clinical study sites, and the EAGLE trial is expected to resume recruitment shortly, without amendments to either protocol. AstraZeneca will progressively resume enrolment for all HNSCC trials across the participating sites in the USA and globally, subject to national health authority and ethics committee approval where required.

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