AstraZeneca PLC Selumetinib granted Orphan Drug Designation by FDA (5273K)
April 17 2015 - 2:00AM
UK Regulatory
TIDMAZN
RNS Number : 5273K
AstraZeneca PLC
17 April 2015
SELUMETINIB granted Orphan Drug Designation by US FDA for
treatment of UVEAL MELANOMA
AstraZeneca today announced that the US Food and Drug
Administration has granted Orphan Drug Designation for the MEK
inhibitor selumetinib, for the treatment of uveal melanoma.
Uveal melanoma is a rare disease in which cancer cells form in
the tissues of the eye. It is the most common primary intraocular
malignancy in adults and comprises 5% of all melanomas(1,2) .
"Uveal melanoma is a rare and devastating disease for which
there are currently no effective treatment options once it spreads
beyond the tissues of the eye. Selumetinib could potentially become
the first effective treatment for these patients. The Orphan Drug
Designation is an important regulatory advancement as we further
our development plans for selumetinib in uveal melanoma," said
Antoine Yver, Head of Oncology, Global Medicines Development at
AstraZeneca.
The Orphan Drug Designation programme provides orphan status to
drugs and biologics, which are defined as those intended for the
safe and effective treatment, diagnosis or prevention of rare
diseases or disorders that affect fewer than 200,000 people in the
US(3) .
Selumetinib, originally licensed from Array BioPharma Inc.,
inhibits the MEK pathway in cancer cells to prevent the tumour from
growing. Data from a phase III study evaluating selumetinib in
combination with chemotherapy in patients with first-line
metastatic uveal melanoma is expected to be available later this
year. In addition to uveal melanoma, selumetinib is being
investigated in Phase III studies in KRAS mutation positive lung
cancer and thyroid cancer and in Phase II in children with
neurofibromatosis Type 1.
Initial data from a combination study of selumetinib with other
AstraZeneca pipeline molecules including AZD9291 (T790M-directed
EGFR inhibitor) and MEDI4736 (anti-PD-L1) in non-small cell lung
cancer will be presented at the American Society of Clinical
Oncology (ASCO) annual meeting 2015.
(1) Egan KM, et al. Surv Ophthalmol 1988; 32: 239-51
(2.) Ramaiya KJ, Harbour JW. Expert Rev Ophthalmol 2007; 2:
939-46
(3) US Food and Drug Administration. Developing Products for
Rare Diseases & Conditions
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm
Accessed on 31 March 2015
About AstraZeneca in Oncology
Oncology is a therapeutic area in which AstraZeneca has
deep-rooted heritage. It will be potentially transformational for
the company's future, becoming the sixth growth platform. Our
vision is to help patients by redefining the cancer treatment
paradigm and one-day eliminate cancer as cause of death. By 2020,
we are aiming to bring six new cancer medicines to patients.
Our broad pipeline of next-generation medicines is focused on
four main disease areas - ovarian, lung, breast, and haematological
cancers. These are being targeted through four key platforms -
immuno-oncology, the genetic drivers of cancer and resistance, DNA
damage repair and antibody drug conjugates.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialisation of prescription medicines, primarily for the
treatment of cardiovascular, metabolic, respiratory, inflammation,
autoimmune, oncology, infection and neuroscience diseases.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more
information please visit: www.astrazeneca.com
CONTACTS
Media Enquiries
Esra Erkal-Paler +44 20 7604 8030 (UK/Global)
Vanessa Rhodes +44 20 7604 8037 (UK/Global)
Ayesha Bharmal +44 20 7604 8034 (UK/Global)
Jacob Lund +46 8 553 260 20 (Sweden)
Michele Meixell + 1 302 885 6351 (US)
Investor Enquiries
Thomas Kudsk Larsen +44 20 7604 8199 mob: +44 7818 524185
Karl Hård +44 20 7604 8123 mob: +44 7789 654364
Eugenia Litz +44 20 7604 8233 mob: +44 7884 735627
Craig Marks +44 20 7 604 8591 mob: +44 7881 615764
Christer Gruvris +44 20 7604 8126 mob: +44 7827 836825
17 April 2015
-ENDS-
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCEDLBFEZFXBBF
Astrazeneca (LSE:AZN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Astrazeneca (LSE:AZN)
Historical Stock Chart
From Apr 2023 to Apr 2024