AstraZeneca PLC LYNPARZAT APPROVED IN THE EUROPEAN UNION (1399A)
December 18 2014 - 2:00AM
UK Regulatory
TIDMAZN
RNS Number : 1399A
AstraZeneca PLC
18 December 2014
LYNPARZA(TM) approved IN THE EUROPEAN UNION as FIRST-IN-CLASS
treatment for ADVANCED BRCA-MUTATED OVARIAN CANCER
AstraZeneca today announced that the European Commission (EC)
has granted Marketing Authorisation for Lynparza(TM) (olaparib)
capsules (400mg twice daily) as the first therapy for the
maintenance treatment of adult patients with platinum-sensitive
relapsed BRCA-mutated (germline and/or somatic) high grade serous
epithelial ovarian, fallopian tube, or primary peritoneal cancer
who are in complete response or partial response to platinum-based
chemotherapy.
Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor that
exploits tumour DNA repair pathway deficiencies to preferentially
kill cancer cells. It is the first PARP inhibitor to be approved
for patients with platinum-sensitive relapsed BRCA-mutated ovarian
cancer. Patients will be identified through a validated diagnostic
test.
"We are delighted to be able to bring this much needed treatment
to patients with BRCA-mutated ovarian cancer whose options are
currently very limited. Today's approval marks a significant
milestone in the development of the next generation of targeted
medicines," said Briggs Morrison, Executive Vice President, Global
Medicines Development and Chief Medical Officer at AstraZeneca. "We
are committed to bringing new treatments to the patients who need
them most and today's news marks only the first of what we hope
will be a number of indications in which Lynparza has the potential
to transform the lives of cancer patients, including those with
breast, pancreatic and gastric cancers."
The EC decision is applicable to all 28 EU member states as well
as Norway, Iceland and Liechtenstein. The approval of olaparib was
based on data from Study 19(1) , a Phase II clinical trial that
evaluated its efficacy and safety compared to placebo in
platinum-sensitive relapsed high grade serous ovarian cancer
patients. The study showed that olaparib maintenance therapy
significantly prolonged progression free survival (PFS) compared
with placebo in patients with BRCA-mutated ovarian cancer: median
PFS 11.2 months vs 4.3 months (PFS Hazard Ratio = 0.18; 95%
Confidence Interval 0.10-0.31; p<0.0001). The most common
adverse events associated with olaparib monotherapy to date were
generally mild to moderate and included nausea, vomiting, fatigue
and anaemia.
Professor Steve Jackson, scientist at the University of
Cambridge, whose research established the basis for olaparib and
its clinical potential said: "It is wonderful to learn that
olaparib is set to become a licensed drug and will therefore soon
become available to advanced ovarian cancer sufferers. I also look
forward to learning the results of ongoing trials exploring
olaparib's potential for the treatment of other cancers. Today's
announcement highlights how, by collaborating with a partner such
as AstraZeneca, basic academic research, such as that carried out
by the research team at the University of Cambridge, can lead to
major medical developments."
"It is fantastic news that Lynparza will now be available for
women with advanced relapsed BRCA-mutated ovarian cancer," said Dr
John Green, Senior Lecturer, Institute of Translational Medicine,
University of Liverpool and Chair, European Network of
Gynaecological Cancer Advocacy Groups (ENGAGe). "This is a
devastating disease which has a profound impact on patients and
their families. Women with a BRCA mutation are especially at risk
and there has been a significant need for new treatment options
with novel modes of action. The development of a targeted treatment
like Lynparza is an excellent example of pioneering research being
translated into a treatment that has the potential to transform the
lives of patients."
(1) Ledermann J et al. Olaparib maintenance therapy in patients
with platinum-sensitive relapsed serous ovarian cancer: a
preplanned retrospective analysis of outcomes by BRCA status in a
randomised phase 2 trial. Lancet Oncology. 2014. 15:852-861.
Additional commentary
Harpal Kumar, chief executive of Cancer Research UK, said: "It's
great news that the European Commission has approved the use of
olaparib within the European Union, especially when Cancer Research
UK scientists played a crucial role in discovering and developing
this new generation of cancer drugs. This drug offers new hope to
women with advanced ovarian cancer by targeting the weaknesses
cancer cells have in repairing damaged DNA. With clinical trial
results showing this treatment has potential in other types of
cancer, we hope there will be more good news in the future. Our
partnerships with AstraZeneca are helping us to bring more new
treatments to patients, accelerating our efforts to beat cancer
sooner."
About Lynparza(TM) (olaparib)
Olaparib is an innovative, first-in-class oral poly ADP-ribose
polymerase (PARP) inhibitor that exploits tumour DNA repair
pathways deficiencies to preferentially kill cancer cells. This
mode of action gives olaparib the potential for activity in a range
of tumour types with DNA repair deficiencies.
In addition to ovarian cancer, AstraZeneca will investigate the
full potential of olaparib in multiple tumour types, with Phase III
studies in second line gastric cancer, BRCA-mutated pancreatic
cancer and adjuvant and metastaticBRCA-mutated breast cancers
underway.
About ovarian cancer
In Europe, ovarian cancer is the fifth most commonly diagnosed
cancer in women and the sixth leading cause of cancer death among
women, mainly because it is often diagnosed late by which time the
patient has an extremely poor prognosis. For the 61% of ovarian
cancer patients whose cancer has metastasised by the time of
diagnosis, the five-year survival rate is only 27%.
Up to 15% of women with ovarian cancer have a BRCA mutation,
which is the most common cause of homologous repair deficiency. In
BRCA-mutated tumour cells, homologous recombination is defective
and DNA double-strand break repair is forced to occur via
error-prone pathways, which can lead to genomic instability and
cell death.
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
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18 December 2014
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