AstraZeneca head and neck cancer trials

AstraZenecaFollowing the recent update on clinicaltrials.gov, AstraZeneca confirms that the US FDA 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. All trials are continuing with existing patients.

The partial clinical hold on new patient enrolment relates only to head and neck cancer. 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.

The FDA's decision follows voluntary action by AstraZeneca to pause enrolment of new HNSCC patients while a detailed analysis is conducted of adverse events related to bleeding that were observed as part of routine safety monitoring of the Phase III KESTREL and EAGLE trials. Bleeding is a known complication in treatments of head and neck cancers primarily due to the nature of the underlying disease, the proximity of tumours 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 enrolment as soon as possible.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Most Popular Now

FDA grants priority review to Roche's cancer immun…

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) a...

Kymriah® (tisagenlecleucel), first-in-class CAR-T …

Novartis today announced the US Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for its second indication ...

Daily aspirin linked to higher risk in men

Men who take once-daily aspirin have nearly double the risk of melanoma compared to men who are not exposed to daily aspirin, reports a new Northwestern Medicine study. W...

New leads on treating dementia and Alzheimer's

A new research study by scientists in Australia and the US provides an explanation for why clinical trials of drugs reducing proteins in the brain that were thought to ca...

Roche reports a strong start in 2018

Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced that in the first three months of 2018, Group sales rose 6% to CHF 13.6 billion. Sales in the Pharmaceuticals Division in...

To treat pain, you need to treat the patient

People in chronic pain are some of the most difficult patients to treat. They have complex circumstances that medicine can't always remedy. Pain can be amplified, by depr...

Novo Nordisk participates in new research project …

Within the newly started European research project Hypo-RESOLVE, 23 leading international players from academia, industry and civil society have joined forces to find bet...

Chemical octopus catches sneaky cancer clues, trac…

Cancer drops sparse chemical hints of its presence early on, but unfortunately, many of them are in a class of biochemicals that could not be detected thoroughly, until n...

Alcon Cares Project 100 commits to reducing catara…

Alcon, the global leader in eye care and a division of Novartis, has announced Alcon Cares Project 100, which aims to reduce cataract blindness by providing equipment to ...

FDA approves novel preventive treatment for migrai…

The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly se...

First clues to the causes of multiple sclerosis

Multiple sclerosis, which affects 1 in 1,000 people, is frequently characterised by relapses associated with variable functional impairments including among others vision...

Doctors in US and Canada launch sweeping pharmaceu…

The skyrocketing cost of prescription drugs is one of the biggest concerns for American voters. However, in his proposal last Friday, President Donald Trump failed to off...