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2018-01-19

AstraZeneca: Lynparza receives approval in Japan for the treatment of advanced ovarian cancer

Lynparza is the first PARP inhibitor approved in Japan

Lynparza tablets approved as maintenance treatment for women with
platinum-

sensitive relapsed ovarian cancer regardless of BRCA mutation status
AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD
outside the US and Canada) today announced that the Japanese Ministry
of Health, Labour and Welfare has approved Lynparza (olaparib)
tablets (300mg twice daily) for use as a maintenance therapy for
patients with platinum-sensitive relapsed ovarian cancer, regardless
of their BRCA mutation status, who responded to their last
platinum-based chemotherapy. Lynparza is the first poly ADP-ribose
polymerase (PARP) inhibitor to be approved in Japan.

Dave Fredrickson, Executive Vice President, Head of the Oncology
Business Unit at AstraZeneca, said: "We are proud to bring this
important first-in-class treatment to women with platinum-sensitive
relapsed ovarian cancer in Japan who currently have very few
treatment options. The trials show that with Lynparza maintenance
therapy, women with ovarian cancer can live longer without their
disease worsening and Lynparza is well tolerated."

Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories, said:
"Today's decision is significant for Lynparza and, more importantly,
for Japanese patients living with advanced ovarian cancer. Our global
collaboration with AstraZeneca reinforces how our joint efforts can
advance science for patients, and we look forward to working together
to explore the potential of Lynparza across multiple tumour types."

The approval was granted on the basis of two randomised trials of
Lynparza maintenance therapy for platinum-sensitive relapsed ovarian
cancer, SOLO-2 and Study 19.

Table 1. Summary of key efficacy results from randomised trials:

+---------------+--------+---------------+------------------------------+
|Analysis |Reduction in |Reduction in the risk of death|
| |the risk of |(OS) |
| |disease | |
| |progression or | |
| |death (PFS) | |
+---------------+--------+---------------+------------------------------+
|SOLO |Lynparza|70% (HR 0.30 |Data not yet mature |
|-2[gBRCAm]n=295| |[95% CI, 0.22 | |
| | |-0.41], | |
| | |P<0.0001; | |
| | |median 19.1 vs | |
| | |5.5 months by | |
| | |investigator | |
| | |-assessed | |
| | |analysis) | |
+---------------+--------+---------------+------------------------------+
|Placebo |
+---------------+--------+---------------+------------------------------+
|Study 19[PSR |Lynparza|65% (HR 0.35 |27% (HR 0.73 [95% CI, 0.55 |
|OC*]n=265 | |[95% CI, 0.25 |-0.95]; median 29.8 vs 27.8 |
| | |-0.49], |months) |
| | |P<0.0001;median| |
| | |8.4 vs 4.8 | |
| | |months) | |
+---------------+--------+---------------+------------------------------+
|Placebo |
+---------------+--------+---------------+------------------------------+

*PSR = Platinum-sensitive recurrent ovarian cancer

In SOLO-2, the most common adverse drug reactions (?20%) of any grade
reported in patients in the Lynparza arm were nausea (66.7%), anaemia
(39.0%), fatigue (29.7%), vomiting (25.6%), asthenia (24.1%) and
dysgeusia (23.1%).

In Study 19, the most common adverse drug reactions (?20%) of any
grade reported in patients in the Lynparza arm were nausea (64.0%),
fatigue (43.4%) and vomiting (21.3%).

Lynparza is also currently under review for use in unresectable or
recurrent BRCA-mutated, HER2-negative breast cancer in Japan, with a
decision expected in the second half of 2018 based upon a priority
review.

-ENDS-

Notes to Editors

About Ovarian Cancer in Japan

Worldwide, ovarian cancer is the seventh most-commonly diagnosed
cancer and the eighth most-common cause of cancer deaths in women. In
Japan, more than 9,000 women are diagnosed with ovarian cancer every
year and the five-year survival rate is 58%, the lowest among all
gynaecological cancers. In 2012, 4,758 women with ovarian cancer
died, which represents one out of every two patients. As there is no
cure for relapsed ovarian cancer, the primary aim of treatment is to
slow progression of the disease for as long as possible and improving
or maintaining a patient's quality of life.

About SOLO-2

SOLO-2 was a Phase III, randomised, double-blinded, multicentre trial
designed to determine the efficacy of Lynparza tablets as a
maintenance monotherapy compared with placebo, in patients with
platinum-sensitive, relapsed or recurrent gBRCA-mutated ovarian,
fallopian tube and primary peritoneal cancer. The trial, conducted in
collaboration with the European Network for Gynaecological
Oncological Trial Groups (ENGOT) and Groupe d'Investigateurs National
pour l'Etude des Cancers de l'Ovaire et du sein (GINECO), randomised
295 patients with documented germline BRCA1 or BRCA2 mutations who
had received at least two prior lines of platinum-based chemotherapy
and were in complete or partial response. Eligible patients were
randomised to receive 300mg Lynparza tablets twice daily or placebo
tablets twice daily.

About Study 19

Study 19 was a Phase II, randomised, double-blinded,
placebo-controlled, multicentre trial, which evaluated the efficacy
and safety of Lynparza compared with placebo in relapsed, high-grade
serous ovarian cancer patients. The trial randomised 265 patients
regardless of BRCA mutation status and who had completed at least two
courses of platinum-based chemotherapy and their most recent
treatment regimen. Eligible patients were randomised to receive
Lynparza maintenance monotherapy at a dose of 400mg per day or
matching placebo.

About Lynparza (olaparib)

Lynparza is a first-in-class poly ADP-ribose polymerase (PARP)
inhibitor and the first targeted treatment to potentially exploit
tumour DNA damage response (DDR)-pathway deficiencies 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 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. The
collaboration is based on increasing evidence that PARP and MEK
inhibitors can be combined with PD-L1/PD-1 inhibitors for a range of
tumour types. Working together, the companies will develop Lynparza
and selumetinib in combination with other potential new medicines and
as a monotherapy. 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 New Oncology as one of AstraZeneca's five Growth
Platforms 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 & Metabolic Diseases
and Respiratory. The Company also is selectively active in the areas
of autoimmunity, neuroscience and infection. 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.

Media Relations
Esra Erkal-Paler UK/Global +44 203 749 5638
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Matt Kent UK/Global +44 203 749 5906
Gonzalo Viña UK/Global +44 203 749 5916
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677

Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Craig Marks Finance, Fixed Income, M&A +44 7881 615 764
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Mitchell Chan Oncology; Other +1 240 477 3771
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