Tuesday, 21 February 2012
AstraZeneca today announced that the European Commission has granted marketing authorisation for CAPRELSA® (vandetanib) for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. CAPRELSA is the first approved treatment for advanced MTC in Europe.
This European Commission decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 17 November 2011 and is applicable to all 27 Member States of the European Union.
“Advanced Medullary Thyroid Cancer is a rare disease with a poor prognosis and clinical outcomes for patients with advanced MTC have not changed substantially in the past 20 years.” said AstraZeneca’s Dr. James Vasselli, CAPRELSA Medical Science Director. “CAPRELSA offers a new treatment option for these patients. It is the first advance of its kind for this devastating disease and we are delighted CAPRELSA has been approved for use in Europe.”
CAPRELSA was granted orphan drug status and approved by the US Food and Drug Administration in April 2011. CAPRELSA is also approved in Canada and is under review in Russia, Switzerland, Brazil, Mexico, Argentina and Australia.
The marketing authorisation of CAPRELSA is based on data from the Phase III CAPRELSA clinical trial programme, including the ZETA study, a double-blind trial of 331 patients with advanced MTC that has progressed and spread to other parts of the body, which showed a 54 per cent reduction in risk of disease progression compared to placebo (hazard ratio 0.46; 95% CI, 0.31–0.69; P<0.001). Common side effects observed were diarrhoea, rash, headache, fatigue and hypertension. The incidence of protocol-defined QTc prolongation was 14%.
NOTES TO EDITORS
About CAPRELSA (vandetanib)
CAPRELSA, a prescription oral kinase inhibitor treatment, is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. 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 decision (see important information in sections 4.4 and 5.1 in the Product Information).
Clinical data show that patients benefit from treatment with CAPRELSA regardless of their RET status. The EC has granted this marketing authorisation which is conditional upon the completion of an observational trial. AstraZeneca will conduct this study to generate additional data to confirm the benefits in patients who are RET negative.
CAPRELSA uses two distinctive mechanisms of action – blocking the blood supply to the tumour by slowing the VEGF (vascular endothelial growth factor receptor) pathway and reducing the growth and survival of the tumour through EGFR (epidermal growth factor receptor) and RET (rearranged during transfection) pathways.
CAPRELSA is a registered trademark of the AstraZeneca group of companies.
About medullary thyroid cancer
Thyroid cancer affects approximately 48,000 people annually in Europe with an estimated mortality rate of 6,300. There are four types of thyroid cancer; papillary and follicular are the most common with anaplastic and medullary being less common (5 to 10 per cent of thyroid cancers are medullary). Medullary thyroid cancer (MTC) differs from papillary and follicular types as it does not arise from the thyroid cells themselves, but rather from the specialised "C-cells" that are in between the thyroid cells. These C-cells are found mostly in the upper and middle parts of the thyroid and produce a substance called calcitonin which can serve as a marker for the progression of MTC.
Approximately 25 per cent of all MTC cases are genetic in nature, caused by a mutation in the RET proto-oncogene. This is referred to as familial MTC and is likely to be diagnosed and treated in patients earlier. When there is no family history, MTC occurs by itself and is referred to as sporadic MTC. Patients who develop sporadic MTC tend to be older and present with more advanced stages of cancer at the time of initial diagnosis, compared to those with family history.
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