Alderley Park, England (ots/PRNewswire)
- AstraZeneca announced
today that it has received positive opinion from the Committee for
Orphan Medicinal Products (COMP) recommending orphan drug designation
for ZD6474 (ZACTIMA(TM)) for the treatment of patients with medullary
thyroid cancer in the European Union (EU). Final adoption of the
opinion is expected from the European Commission in early 2006.
ZD6474 is a once-daily oral therapy that selectively targets key
cell signalling pathways involved in tumour growth and spread
including VEGF (Vascular Endothelial Growth Factor) receptor
signalling and EGF (Epidermal Growth Factor) receptor signalling.
ZD6474 also inhibits RET kinase, which drives the growth and survival
of certain tumours, and is believed to be an important pathway in
medullary thyroid cancer.
"The COMP's recommendation adds further momentum behind the
development of ZD6474 and represents a major step forward in the EU
orphan drug designation process," said Peter Langmuir MD, Senior
Medical Science Director, AstraZeneca. "EU orphan drug designation
would offer hope for patients in Europe with medullary thyroid
cancer, where treatment options are limited and the prognosis is
A recent presentation of preliminary results from a Phase II study
during the AACR-NCI-EORTC International Conference on Molecular
Targets and Cancer Therapeutics in November 2005 showed promising
clinical data with ZD6474 (ZACTIMATM) in patients with hereditary
medullary thyroid cancer(1). A Phase II study evaluating the
anti-tumour efficacy and safety of ZD6474 in patients with advanced
hereditary medullary thyroid cancer is currently ongoing and
continues to recruit patients.
EU orphan drug designation was designed to encourage the
development of products that demonstrate promise for the diagnosis,
prevention and/or treatment of life-threatening or very serious
conditions that are rare and affect not more than 5 in 10,000 persons
in the European Union.
Thyroid cancer affects 240,989 individuals in Europe(2). Current
treatments for thyroid cancer include surgery, radioactive iodine,
hormone treatment, external radiation or chemotherapy. Medullary
thyroid cancer is a specific form of the disease accounting for 5-8%
of the 25,000 new cases of thyroid cancer in Europe each year.2
Advanced hereditary medullary thyroid cancer, a rare malignancy, has
a poor prognosis and there are currently very limited therapeutic
options available. Neither standard chemotherapy regimens, nor
radiation therapy, provide substantial benefits for patients with
advanced hereditary medullary thyroid cancer.
ZD6474 received U.S. FDA orphan drug designation in October 2005
for patients with follicular, medullary, anaplastic, and locally
advanced and metastatic papillary thyroid cancer, the first oncology
orphan drug designation AstraZeneca has received.
ZACTIMA(TM) (ZD6474) is a trademark of the AstraZeneca group of
About ZD6474 (ZACTIMATM)
ZD6474 targets tumour blood supply, by inhibiting VEGFR (vascular
endothelial growth factor receptor) tyrosine kinase, and directly
targets tumour cells, by inhibiting EGFR (epidermal growth factor
receptor) and RET tyrosine kinases. ZD6474 is currently being
developed in a Phase II clinical trial in medullary thyroid cancer.
In July 2005, AstraZeneca announced its intention to progress into
Phase III studies evaluating the anti-tumour activity of ZD6474 in
advanced non-small cell lung cancer (NSCLC). ZACTIMA(TM) (ZD6474) is
a trademark of the AstraZeneca group of companies.
AstraZeneca is a major international healthcare business engaged
in the research, development, manufacture and marketing of
prescription pharmaceuticals and the supply of healthcare services.
It is one of the world's leading pharmaceutical companies with
healthcare sales of over $21.4 billion and leading positions in sales
of gastrointestinal, cardiovascular, respiratory, oncology and
neuroscience products. AstraZeneca is listed in the Dow Jones
Sustainability Index (Global) as well as the FTSE4Good Index.
For more information about AstraZeneca, please visit:
1. Wells S et al. The Use of ZACTIMA(TM) (ZD6474) in the Treatment
of Patients with Hereditary Medullary Thyroid Carcinoma. Presented at
the AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics, November 2005.
2. J. Ferlay, F. Bray, P. Pisani and D.M. Parkin. GLOBOCAN 2000:
Cancer Incidence, Mortality and Prevalence Worldwide.
ots Originaltext: AstraZeneca
Im Internet recherchierbar: http://www.presseportal.ch
For more information, contact: Peter Edwards Global PR Manager -
Oncology, Tel: +44-(0)1625-232685, Mobile: +44-(0)-7747-118-498,
; Janet Milton-Edwards, Global PR
Director - IRESSA & ZACTIMA, Tel: +44-(0)-1625-515-275, Mobile: