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2014-06-26

AstraZeneca: AstraZeneca PLC Announces FDA Advisory Committee Votes on Accelerated Approval for Investigational Medicine Olaparib

AstraZeneca today announced that the US Food and Drug Administration
(FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 that
current evidence from clinical studies does not support an
accelerated approval for use of olaparib as a maintenance treatment
for women with platinum-sensitive relapsed ovarian cancer who have
the germline BRCA (gBRCA) mutation, and who are in complete or
partial response to platinum-based chemotherapy.

The ODAC provides the FDA with independent, expert advice and
recommendations, however the final decision regarding approval is
made by the FDA.

AstraZeneca filed the US regulatory submission for olaparib in
February 2014. The FDA granted priority review status for the NDA in
April and set a Prescription Drug User Fee Act (PDUFA) action date of
3 October 2014.

Briggs Morrison, Executive Vice President, Global Medicines
Development and Chief Medical Officer at AstraZeneca said: "Patients
with germline BRCA-mutated serous ovarian cancer have few options
available to treat this disease. We are disappointed with today's
recommendation, and strongly believe that olaparib has the potential
to provide patients with relapsed BRCA-mutated ovarian cancer and
their doctors with a much-needed treatment option. We look forward
to continuing to work with the FDA as it evaluates the Advisory
Committee recommendation and completes its review of the application.
In the meantime, we are continuing with our Phase III clinical
programme to evaluate the benefit of olaparib for this patient
population. We aim to have completed this study by the end of 2015."

The NDA filing was based on a subgroup analysis of Phase II data
recently published in Lancet Oncology1. The Phase II study was a
randomised, double-blind, placebo-controlled trial which evaluated
olaparib versus placebo as maintenance treatment in
platinum-sensitive relapsed serous ovarian cancer patients who had
received previous treatment with at least two platinum regimens and
were in a maintained partial or complete response following their
last platinum regimen. The study met its primary endpoint of
progression-free survival by Response Evaluation Criteria in Solid
Tumours guidelines. A pre-defined subgroup analysis was conducted in
patients who have germline BRCA mutations.

In addition, as part of its commitment to bring the potential benefits
of olaparib to ovarian cancer patients, AstraZeneca has initiated and
is committed to complete the Phase III SOLO programme
(http://www.astrazeneca.com/Media/Press-releases/Article/astrazeneca-enro...),
designed to evaluate the efficacy and safety of olaparib as a
maintenance monotherapy in ovarian cancer patients who have a BRCA
mutation who are in complete or partial response following
platinum-based chemotherapy in the relapsed setting.

1 Ledermann JA, 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 II study. The Lancet Oncology 2014.
http://dx.doi.org/10.1016/S1470-2045(14)70228-1.

About olaparib

Olaparib is an innovative, investigational, potential first-in-class
oral poly ADP ribose polymerase (PARP) inhibitor that exploits tumour
DNA repair pathway deficiencies to selectively induce cancer cell
death. This mode of action gives olaparib the potential for activity
in a range of tumour types with DNA repair deficiencies.

PARP is a key enzyme in one of the DNA repair pathways in human cells.
Inhibition of PARP results in a build-up of DNA damage in the cell,
requiring repair via an alternative pathway called Homologous
Recombination repair (HR). Cancer cells that already have a HR
pathway deficiency (HRD) are limited in their ability to repair their
DNA, overloading them with DNA damage and causing them to die. A
number of abnormalities can cause HRD in cancer cells including BRCA
gene mutations. HRD is associated with a range of tumor types, in
particular with breast and ovarian cancers.

In addition to ovarian cancer, olaparib is being investigated in
combination with chemotherapy in second-line gastric cancer in the
GOLD study, while Phase III studies evaluating olaparib in adjuvant
and metastatic breast cancer with BRCA mutations have recently been
initiated.

About ovarian cancer

Ovarian cancer is the eighth most commonly diagnosed cancer in women
and the seventh leading cause of cancer death among women worldwide,
mainly because it is often diagnosed late and has an extremely poor
prognosis. For the 75% of ovarian cancer patients whose cancer has
spread by the time of diagnosis, the five-year survival rate is less
than 50%, so there is a real need for additional therapies beyond
current standard of care, which is platinum-based chemotherapy.

Women with BRCA1 or BRCA2 mutations have an increased risk of
developing ovarian cancer, and the course of their disease is similar
to that of the overall patient population. Up to 40% of patients with
platinum-sensitive relapsed ovarian cancer harbour a BRCA mutation,
which is the most common cause of HRD.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialization 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)
Michele Meixell +1 302 885 2677 (US)
Jacob Lund +46 8 553 260 20 (Sweden)

Investor Enquiries
Karl Hård +44 20 7604 8123 
mob: +44 7789 654364
Colleen Proctor + 1 302 886 1842
mob: +1 302 357 4882
Anthony Brown +44 20 7604 8067
mob: +44 7585 404943
Jens Lindberg +44 20 7604 8414
mob: +44 7557 319729

26 June 2014

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http://news.cision.com/astrazeneca/r/astrazeneca-plc-announces-fda-advis...
http://mb.cision.com/Main/309/9608029/260806.pdf

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