FDA puts partial clinical hold on two AstraZeneca cancer drug trials

Following the recent update on clinicaltrials.gov, Anglo-Swedish pharma major AstraZeneca (LSE: AZN) confirms that the US Food and Drug Administration has placed a partial clinical hold on the enrolment of new patients with head and neck squamous cell carcinoma (HNSCC) in clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential medicines.

News of the FDA action caused AstraZeneca’s shares to fall 4% to $28.43 in late US trading yesterday, given that durvalumab is seen as one of the company’ most important pipeline drugs. Analysts at Jefferies have forecast peak sales of $500 million a year for the treatment of head and neck cancer alone. The drug is under development for other cancers, such as lung, bladder, gastric, pancreatic and blood cancers.

All trials are continuing with existing patients. The partial clinical hold on new patient enrolment relates only to head and neck cancer, AstraZeneca explained. Trials for durvalumab in different cancer types, as monotherapy or in combination with tremelimumab or other potential medicines, are progressing as planned, with pivotal data in lung cancer anticipated in the first half of 2017.