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CHMP recommends AZ's thyroid cancer drug Caprelsa for approval

EMA's advisory committee backs the drug's use against aggressive and symptomatic medullary thyroid cancer

European regulatory advisors have given the green light to AstraZeneca's thyroid cancer treatment Caprelsa (vandetanib).

The CHMP issued a positive opinion on Caprelsa's use against aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.

Positive opinions are usually followed by a full regulatory approval from the European Commission within three months and if approved Caprelsa would become the first licensed treatment in Europe for advanced MTC.

But Caprelsa's proposed recommendation says that, for patients in whom Rearranged during Transfection (RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions.

While AstraZeneca said clinical data showed patients benefited from Caprelsa regardless of their RET status, the CHMP wants the pharma company to conduct a further study to generate additional data to confirm the benefits in patients who are RET negative.

The CHMP's recommendation was based on phase III trial data that included the ZETA study. A double-blind trial of 331 patients with advanced MTC that has progressed and spread to other parts of the body, ZETA showed a 54 per cent reduction in risk for disease progression compared to placebo.

In Europe, thyroid cancer affects approximately 48,000 people each year with an estimated mortality rate of 6,300 of which 5 to 10 per cent have medullary thyroid cancer.

Advanced MTC has a poor prognosis and clinical outcomes for patients with this disease have not changed substantially in the past 20 years.

18th November 2011

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