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FDA suspends recruitment in AstraZeneca's clinical trials of durvalumab in head and neck cancer due to bleeding events; shares down 4%

Published 10/27/2016, 03:56 PM
Updated 10/27/2016, 03:56 PM
FDA suspends recruitment in AstraZeneca's clinical trials of durvalumab in head and neck cancer due to bleeding events; shares down 4%
  • AstraZeneca (AZN -3.6%) heads south on triple normal volume on the heels of its announcement that the FDA has placed a partial clinical hold on its clinical trials assessing durvalumab in patients with head and neck squamous cell carcinoma (HNSCC).
  • The partial clinical hold, which suspends recruitment, was instituted so an analysis can be made on adverse events related to bleeding. The effort is part of routine safety monitoring of the Phase 3 KESTREL and EAGLE studies.
  • Bleeding is a common complication in therapies to treat HNSCC due to the nature of the disease, the proximity of tumors to major blood vessels and prior treatments such as surgery and radiation.

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