CAPRELSA? (vandetanib) Receives Positive CHMP Opinion in the European Union for Treating Advanced Medullary Thyroid Cancer

London, November 18 (ots/PRNewswire) -

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
and Switzerland.

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

CHMP opinion

A positive opinion has been granted by the CHMP regarding the
following proposed indication:

'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 Product Information).'

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.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical
business with a primary focus on the discovery, development and
commercialisation of prescription medicines for gastrointestinal,
cardiovascular, neuroscience, respiratory and inflammation, oncology
and infectious disease. AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients
worldwide. For more information please visit:
http://www.astrazeneca.com

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