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AstraZeneca’s Caprelsa wins recommendation from CHMP
AstraZeneca has earned a recommendation for approval from Europe's Committee for Medicinal Products for Human Use (CHMP) for the new cancer drug Caprelsa.
The European Medicines Agency committee has endorsed the company's submission for ratification of the therapy, which is intended for the treatment of aggressive and symptomatic medullary thyroid cancer among patients with unresectable locally advanced or metastatic disease.
Data from phase III clinical studies has shown it can deliver benefits regardless of patients' RET status, with further research to be conducted to assess its effect on those who are RET negative.
The European Commission will now evaluate this recommendation before reaching a final decision on Caprelsa, which received approval from the US Food and Drug Administration in April 2011.
Currently, there are now approved therapies available in Europe for advanced stages of thyroid cancer, making this a potentially important new treatment option.
Last week, AstraZeneca published new data from a clinical study that reinforced the benefits of Crestor, its approved therapy for atherosclerosis.
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