Please login to the form below

Not currently logged in
Email:
Password:

Priority review for AZ's thyroid cancer drug

The US Food and Drug Administration has granted priority review status for AstraZeneca's thyroid cancer drug vandetanib

The US Food and Drug Administration (FDA) has granted priority review status for AstraZeneca's (AZ) vandetanib – developed for the treatment of advanced medullary thyroid cancer (MTC).

The confirmation of the priority review came as the Anglo-Swedish drugmaker announced it had submitted the treatment for regulatory approval from both the FDA and the European Medicines Agency (EMA).

The applications follow AZ's phase III ZETA study to evaluate the safety and efficacy of the drug. In the trial, a once-daily dose of vandetanib 300mg was found to significantly extend progression-free survival in patients with MTC.

According to the American Cancer Society, there will be 44,000 new cases of thyroid cancer diagnosed in the US in 2010, with MTC accounting for five per cent of these.

Current treatments include surgery, although there are limited options for advanced stages of the disease. Radioiodine treatment – a common therapy in other forms of thyroid cancer – is not suitable for MTC.

AZ had previously submitted vandetanib for approval in both the US and EU for the treatment of non-small cell lung cancer under the brand name Zactima.

AZ withdrew both applications however after the drug demonstrated no overall survival advantage when used in addition to chemotherapy.

23rd September 2010

Share

Subscribe to our email news alerts

PMHub

Add my company
Onyx Health

Onyx Health is a healthcare communications and PR agency based in the North East of England, but with a national...

Latest intelligence

The evolving healthcare advertising landscape
Industry experts share their insights on the emerging trends in healthcare advertising...
Clinical trial considerations: Why supporting HCPs matters...
When HCPs have the necessary information, they can more easily communicate it to patients using simplified language and a confident, calm tone....
Six ways to provide successful e-learning programs to healthcare professionals
Practical tips to setting up high-impact e-learning programs...