TIDMAZN
RNS Number : 3820A
AstraZeneca PLC
19 December 2014
LYNPARZA(TM) approved by the US FOOD AND DRUG ADMINISTRATION FOR
THE TREATMENT OF ADVANCED OVARIAN CANCER IN PATIENTS WITH GERMLINE
BRCA-MUTATIONS
AstraZeneca today announced that the US Food and Drug
Administration (FDA) has approved LYNPARZA(TM) (olaparib) capsules
(400mg twice daily) as the first monotherapy for patients with
deleterious or suspected deleterious germline BRCA-mutated (gBRCAm)
advanced ovarian cancer, who have been treated with three or more
prior lines of chemotherapy. Olaparib has been approved under the
FDA's Accelerated Approval programme, based on existing objective
response rate and duration of response data. Continued approval for
this indication is contingent upon verification of clinical benefit
in ongoing confirmatory Phase III trials.
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 germline BRCA-mutated advanced ovarian cancer, as
detected by an FDA approved companion diagnostic test, BRACAnalysis
CDx(TM).
Dr. Briggs Morrison, Executive Vice President, Global Medicines
Development and Chief Medical Officer at AstraZeneca, said
"LYNPARZA is an excellent example of how advances in the
understanding of cancer biology can be used to develop the next
generation of targeted medicines. It is a much-needed new
therapeutic option for patients with germline BRCA-mutated advanced
ovarian cancer. Today's approval also marks the first of what we
hope will be a number of indications in which this medicine has the
potential to improve the lives of cancer patients."
AstraZeneca filed a US regulatory submission for olaparib in
February 2014, based on data from a Phase II maintenance study(1)
of olaparib compared to placebo in platinum-sensitive relapsed high
grade serous ovarian cancer patients. Following the FDA Oncologic
Drugs Advisory Committee recommendation on 25 June 2014 and in
response to an FDA request for additional data, AstraZeneca
submitted a major amendment to the olaparib New Drug Application on
24 July 2014. The FDA approval is therefore based on efficacy data
from a single-arm, open-label, Phase II study(2) of olaparib in
patients with deleterious or suspected deleterious germline
BRCA-mutated advanced cancers, as well as safety data from several
other olaparib studies, including the placebo-controlled study.
The efficacy of olaparib is based on analysis of 137 patients
with measurable, germline BRCA mutated advanced ovarian cancer
treated with three or more prior lines of chemotherapy. The trial
results demonstrated an overall response rate of 34% (95%
Confidence Interval: 26%, 42%). The median response duration was
7.9 months (95% Confidence Interval: 5.6, 9.6 months). The most
common adverse events associated with olaparib monotherapy to date
have been generally mild to moderate and have included nausea,
vomiting, fatigue and anaemia.
Dr. Ursula Matulonis, Associate Professor of Medicine, Harvard
Medical School and Director of the Gynaecological Oncology
Programme at the Dana-Farber Cancer Institute, Boston said:
"Ovarian cancer is diagnosed in nearly 22,000 women per year. The
long-term survival rate in patients with advanced ovarian cancer is
10% to 30%. The FDA approval of LYNPARZA is a significant milestone
for our patients as currently there are only limited treatment
options available to women with ovarian cancer who carry the BRCA
mutation."
A full review of data from either of two ongoing studies under
the SOLO Phase III clinical programme will be required for the
accelerated approval of olaparib in BRCA-mutated advanced ovarian
cancer to be converted to a full approval: SOLO2 is evaluating
olaparib compared to placebo as a maintenance therapy and SOLO3 is
evaluating olaparib compared to standard chemotherapy for relapsed
disease. Data from the SOLO2 study is expected in 2015 and data
from SOLO3 is expected in 2019.
The FDA's approval follows the announcement on 18 December of
the approval of olaparib in the European Union, as the first
therapy for the maintenance treatment of adult patients with
platinum-sensitive relapsed BRCA-mutated serous ovarian cancer.
(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.
http://dx.doi.org/10.1016/S1470-2045(14)70228-1
(2) Kaufman B, Shapira-Frommer R, Schmultzler RK et al. Olaparib
Monotherapy in Patients With Advanced Cancer and a Germline BRCA1/2
Mutation. Journal of Clinical Oncology 2014.
http://jco.ascopubs.org/content/early/2014/10/30/JCO.2014.56.2728
About ovarian cancer
Ovarian cancer is the fifth leading cause of cancer death among
women in the United States, mainly because it is often diagnosed
late and 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 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.
Concurrent with the approval of olaparib, the FDA has approved
the BRACAnalysis CDx(TM) (Myriad Genetic Laboratories) for the
qualitative detection and classification of variants in the BRCA1
and BRCA2 genes.
About the Phase III SOLO programme
AstraZeneca initiated the Phase III SOLO programme in September
2013. The programme consists of three studies:
-- SOLO1: designed to evaluate olaparib as a maintenance
monotherapy for ovarian cancer in patients who have a germline BRCA
mutation and who demonstrated a complete or partial response
following first-line platinum-based chemotherapy
-- SOLO2: designed to evaluate olaparib as a maintenance
monotherapy for relapsed ovarian cancer in patients who have a
germline BRCA mutation and who demonstrated a complete or partial
response following platinum-based chemotherapy
-- SOLO3: designed to evaluate olaparib versus non-platinum
chemotherapy as third-line or later treatment for relapsed ovarian
cancer in patients who have a germline BRCA mutation
For further information, please visit:
www.ovariancancertrials.com
In addition to ovarian cancer, AstraZeneca is committed to
investigating the potential of olaparib in multiple tumour types,
with Phase III studies in adjuvant and metastatic BRCA-mutated
breast cancers, BRCA-mutated pancreatic cancer and second line
gastric cancer underway.
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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19 December 2014
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