TIDMAZN
RNS Number : 1185E
AstraZeneca PLC
16 October 2018
16 October 2018 07:00 BST
US FDA grants Lynparza Orphan Drug Designation for pancreatic
cancer
Fourth Orphan Drug Designation in the US for AstraZeneca and
MSD's Lynparza
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US
(Merck: known as MSD outside the US and Canada) today announced
that they were granted orphan drug designation (ODD) by the US Food
and Drug Administration (FDA) for Lynparza (olaparib) for the
treatment of pancreatic cancer.
Pancreatic cancer is a rare, life-threatening disease that
accounts for about 3% of all cancers in the US.(i) Due to the late
onset of symptoms, patients are often diagnosed after the cancer
has progressed to locally advanced or metastatic stages of the
disease.(ii) Five-year survival rates remain low in the US at
8.5%.(iii)
Sean Bohen, Executive Vice President, Global Medicines
Development and Chief Medical Officer said: "Pancreatic cancer is
an area of significant unmet medical need. This is especially true
for patients with metastatic disease where the benefits of current
treatment options are very limited."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, at MSD Research Laboratories,
said: "Pancreatic cancer is a relatively less common, but
life-threatening, form of cancer. The FDA granting Orphan Drug
Designation is a positive step for patients with pancreatic cancer
and continues to reinforce the importance of our collaboration in
bringing Lynparza to more patients in need."
ODD status was granted for the treatment of ovarian cancer in
October 2013. Earlier this year an amended ODD status was granted
to include both fallopian tube and primary peritoneal cancers
following the expanded US approval of Lynparza in August 2017 for
the maintenance treatment of adult patients with recurrent
epithelial ovarian, fallopian tube or primary peritoneal cancer,
who are in a complete or partial response to platinum-based
chemotherapy. The FDA grants ODD status to medicines intended for
the treatment, diagnosis or prevention of rare diseases or
disorders that affect fewer than 200,000 people in the US.
The use of Lynparza in pancreatic cancer is being assessed in
the ongoing Phase III POLO trial, which is testing Lynparza as
maintenance monotherapy vs placebo in patients with germline
BRCA-mutated metastatic pancreatic cancer whose disease has not
progressed following 1st-line platinum-based chemotherapy. Results
from the POLO trial are expected in the first half of 2019.
About the POLO Phase III trial
POLO is a Phase III, randomised, double-blinded,
placebo-controlled trial to evaluate the efficacy and safety of
Lynparza tablets (300 mg twice daily) as maintenance monotherapy
compared with placebo, in patients with germline BRCA-mutated
metastatic pancreatic cancer whose disease has not progressed
following 1st-line platinum-based chemotherapy. The trial
randomised 145 patients to receive Lynparza or placebo (3:2). The
primary endpoint is progression-free survival.
About Lynparza
Lynparza (olaparib) was the first in class PARP inhibitor and
the first targeted treatment to potentially exploit DNA damage
response (DDR) pathway deficiencies, such as BRCA mutations, to
preferentially kill cancer cells. Specifically, in vitro studies
have shown that Lynparza-induced cytotoxicity may involve
inhibition of PARP-enzymatic activity and increased formation of
PARP-DNA complexes, resulting in DNA damage and cancer cell
death.
Lynparza, which has the broadest clinical development programme
of any PARP inhibitor, is being investigated in a range of
DDR-deficient tumour types, and is the foundation of AstraZeneca's
industry-leading portfolio of compounds targeting DDR mechanisms in
cancer cells.
About the AstraZeneca and MSD Strategic Oncology
Collaboration
In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth,
NJ, US, known as MSD outside the United States and Canada,
announced a global strategic oncology collaboration to co-develop
and co-commercialise Lynparza, the world's first PARP inhibitor and
potential new medicine selumetinib, a MEK inhibitor, for multiple
cancer types. Working together, the companies will develop Lynparza
and selumetinib in combination with other potential new medicines
and as monotherapies. Independently, the companies will develop
Lynparza and selumetinib in combination with their respective PD-L1
and PD-1 medicines.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a
quickly-growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. With at
least six new medicines to be launched between 2014 and 2020 and a
broad pipeline of small molecules and biologics in development, we
are committed to advance Oncology as a key growth driver focused on
lung, ovarian, breast and blood cancers. In addition to our core
capabilities, we actively pursue innovative partnerships and
investments that accelerate the delivery of our strategy as
illustrated by our investment in Acerta Pharma in haematology.
By harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - and by championing the development
of personalised combinations, AstraZeneca has the vision to
redefine cancer treatment and one day eliminate cancer as a cause
of death.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal &
Metabolism and Respiratory. 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 and
follow us on Twitter @AstraZeneca.
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Adrian Kemp
Company Secretary
AstraZeneca PLC
(i) American Cancer Society. Key statistics for pancreatic
cancer. Available at:
https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html.
Accessed October 2018.
(ii) Noone AM, Howlader N, Krapcho M, Miller D, Brest A, Yu M,
Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ,
Cronin KA (eds). SEER Cancer Statistics Review, 1975-2015, National
Cancer Institute. Bethesda, MD,
https://seer.cancer.gov/csr/1975_2015/, based on November 2017 SEER
data submission, posted to the SEER website, April 2018.
(iii) Noone AM, Howlader N, Krapcho M, Miller D, Brest A, Yu M,
Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ,
Cronin KA (eds). SEER Cancer Statistics Review, 1975-2015, National
Cancer Institute. Bethesda, MD,
https://seer.cancer.gov/csr/1975_2015/, based on November 2017 SEER
data submission, posted to the SEER website, April 2018.
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END
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