LONDON, Nov. 18, 2011 /CNW/ - AstraZeneca today announced that the
Marketing Authorisation Application for CAPRELSA (vandetanib) received
a positive opinion from the Committee for Medicinal Products for Human
Use (CHMP) for the treatment of aggressive and symptomatic medullary
thyroid cancer (MTC) in patients with unresectable locally advanced or
metastatic disease. The proposed indication also states 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.
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Clinical data show that patients benefit from treatment with CAPRELSA
regardless of their RET status. In line with the CHMP's requirement,
AstraZeneca will conduct a further study to generate additional data to
confirm the benefits in patients who are RET negative.
The opinion was reached after the CHMP reviewed data from the Phase III
CAPRELSA clinical trial programme, including the ZETA study. This
study, a double-blind trial of 331 patients with advanced MTC that has
progressed and spread to other parts of the body, showed a 54 per cent
reduction in risk for disease progression compared to placebo.
In Europe, thyroid cancer affects approximately 48,000 people annually
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. Currently there are no approved
therapies in Europe for this advanced stage of the disease.
The CHMP positive opinion for CAPRELSA will now be reviewed by the
European Commission, which has the authority to approve medicines for
use in the European Union. CAPRELSA was approved by the US Food and
Drug Administration in April 2011 and is also under review in Canada
CAPRELSA is an oral kinase inhibitor using 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.
NOTES TO EDITORS
A positive opinion has been granted by the CHMP regarding the following
'Caprelsa 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
About medullary thyroid cancer
There are four types of thyroid cancer. Papillary and follicular are the
most common with anaplastic and medullary being less common. 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 [http://en.wikipedia.org/wiki/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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