AstraZeneca confirmed that the US Food and Drug Administration ordered a partial clinical hold on the enrolment of new patients with head and neck cancer in clinical trials of duralumin, due to bleeding issues.
The partial clinical hold on new patient enrollment relates only to head and neck cancer. Trials for duralumin in different cancer types, or other potential medicines, are progressing as planned, with data in lung cancer anticipated in the first half of 2017.
The FDA’s decision follows the voluntary action by AstraZeneca to pause enrollment of new patients while a detailed analysis is conducted of bleeding that took place during safety monitoring.
Bleeding is a known complication in treatments of head and neck cancers primarily due to the nature of the underlying disease, the proximity of tumors to major blood vessels and use of prior cancer therapies, which may involve surgery and radiation.
AstraZeneca has submitted its analysis of the observed bleeding events to the FDA for review and is working closely with the Agency, providing the required information to resume new patient enrollment as soon as possible.
Cancer is one of the key areas of drug development for AstraZeneca. The company has sold off lines or dropped research in other areas in working to sharpen its focus and rebuild its drug pipeline after the loss of blockbuster drugs.
