FDA lifts hold for AZ's durvalumab in head and neck cancer

AstraZeneca plc (LSE:AZN; NYSE:AZN) said FDA lifted a partial clinical hold on enrollment of patients with squamous cell carcinoma of the head and neck (SCCHN) in clinical trials of durvalumab (MEDI4736) as monotherapy and in combination with tremelimumab (CP-675) and other candidates.

The agency placed the hold last month after AZ voluntarily paused recruitment in the Phase III KESTREL and EAGLE trials to analyze bleeding events. KESTREL and EAGLE are evaluating durvalumab as monotherapy and in combination with tremelimumab to treat SCCHN in the first- and second-line settings, respectively (see BioCentury Extra, Oct. 27)...