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AstraZeneca wins European approval for thyroid cancer drug Caprelsa

European Commission's decision makes Caprelsa the first drug to be approved in Europe for advanced medullary thyroid cancer

The European Commission has approved AstraZeneca's Caprelsa making it the first licensed treatment for advanced medullary thyroid cancer (MTC) in Europe.

Caprelsa (vandetanib) can now be used to treat patients with a form of the disease that is either inoperable or has spread to other parts of the body. These patients had previously had no alternative treatment option.

The approval follows a positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) based on positive results from phase III trial data that included the ZETA study.

This study involved 331 patients with advanced MTC and the use of Caprelsa was associated with a reduction in disease progression risk of 54 per cent compared to placebo.

The results of this trial also helped the drug win approval in the US, where it received authorisation from the Food and Drug Administration (FDA) in April, 2011, after being granted a priority review.

As part of the US approval process AZ will have to complete a post-approval clinical trial in order to determine whether a lower dose could potentially be effective to help avoid some of the serious safety issues that have been observed in clinical trials, which include a possible increase in the risk of stroke.

Analysts at Reuters said they expect worldwide sales of Caprelsa to peak at around $128m in 2016.

A potential rival to Caprelasa is Exelixis' cabozantinib, which is currently being investigated for use in advanced MTC.

The drug, which also has orphan status in the US, managed to achieve its primary end point in a phase III trial and has a new drug application pending in the US, a response is expected some point during the first half of 2012.

It is estimated that around 48,000 people in Europe have thyroid cancer, with the medullary form of the disease accounting for 5 to 10 per cent of cases.

Medullary thyroid cancer is differentiated form the more common papillary and follicular forms of the disease as it originates in C cells rather than thyroid hormone producing cells.

The standard treatment option is for patients to have a total thyroidectomy – the removal of all lymph nodes and fatty tissues in the central area of the neck – although such surgery is not always possible during advanced stages of the disease.

 

21st February 2012

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