The US Food and Drug Administration lifted the partial clinical hold on the enrollment of new patients with head and neck squamous cell carcinoma (HNSCC) for clinical trials of Astra Zeneca’s durvalumab as monotherapy and in combination with tremelimumab or other potential medicines.
The Phase III Kestrel trial has already reopened for new patient enrollment at some clinical study sites and the Eagle trial is expected to resume recruitment shortly, without amendments to either study.
AstraZeneca will resume enrollment for all HNSCC trials across the participating sites in the US and globally, subject to national health authority and ethics committee approval where required.
The partial clinical hold on new patient enrollment announced in late October after preliminary findings from ongoing clinical trials related specifically to head and neck cancer.
The FDA lifted the partial clinical hold following a review of the comprehensive analysis provided by AstraZeneca of bleeding that was observed as part of the routine safety monitoring of the trials.
Bleeding is a known complication in treatments of head and neck cancers primarily due to the nature of the disease, the proximity of tumors to major blood vessels and use of prior cancer therapies, which may involve surgery and radiation, an AstraZeneca release stated.
AstraZenec’s North American commercial headquarters is located near Wilmington.
