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2019-10-17

AstraZeneca: Trastuzumab deruxtecan granted FDA Priority Review for treatment of patients with HER2-positive metastatic bre...

AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today
announced that the US Food and Drug Administration (FDA) has accepted
for review the Biologics License Application (BLA) for [fam-]
trastuzumab deruxtecan (DS-8201) and granted Priority Review.

The Prescription Drug User Fee Act (PDUFA) date for trastuzumab
deruxtecan, a HER2-targeting antibody drug conjugate (ADC) and
potential new medicine for the treatment of HER2-positive metastatic
breast cancer, is set for the second quarter of 2020.

José Baselga, Executive Vice President, Oncology R&D, said:
"Trastuzumab deruxtecan has the potential to transform the treatment
landscape for patients with HER2-positive metastatic breast cancer
who have limited treatment options today. This Priority Review draws
on the strength and the consistency of results seen in the Phase I
and Phase II trials and is a critical step on the journey to deliver
this potential new medicine to patients."

Antoine Yver, Executive Vice President and Global Head, Oncology
Research and Development, Daiichi Sankyo, said: "We are pleased that
the FDA has accepted the application and granted Priority Review, as
we believe trastuzumab deruxtecan has the potential to redefine the
treatment of patients with HER2-positive metastatic breast cancer.
Following the recent regulatory submission in Japan, we look forward
to working closely with regulatory authorities to bring trastuzumab
deruxtecan to patients in the US and Japan as soon as possible."

Trastuzumab deruxtecan was previously granted US FDA Breakthrough
Therapy Designation and Fast Track designation. The BLA is based on
the combination of data from the Phase I trial published in The
Lancet Oncology
(https://www.astrazeneca.com/media-centre/medical-releases/astrazeneca-an...)[
]and[ ]the pivotal Phase II DESTINY-Breast01 trial.[1] The response
rate observed in DESTINY-Breast01, as assessed by an independent
review committee, validated the clinical activity observed in the
Phase I trial. Detailed data from DESTINY-Breast01 will be presented
at the forthcoming San Antonio Breast Cancer Symposium in December.

About HER2

HER2 is a tyrosine kinase receptor growth-promoting protein found on
the surface of some cancer cells that is associated with aggressive
disease and poorer prognosis in breast cancer patients.2 To be
considered HER2-positive, tumour cancer cells are usually tested by
one of two methods: immunohistochemistry (IHC) or fluorescent in situ
hybridisation (FISH). IHC test results are reported as: 0, IHC 1+,
IHC 2+, or IHC 3+.[2] A finding of IHC 3+ and/or FISH amplification
is considered positive.[2]

About HER2-positive breast cancer

Approximately one in five breast cancers are HER2-positive.3[,4][
]Despite recent improvements and approvals of new medicines, there
remains significant clinical needs for patients with advanced
HER2-positive metastatic breast cancer.[5,6] This disease remains
incurable with patients eventually progressing after available
treatments.[5,6 ]Additionally, there are currently no approved
HER2-targeted medicines for HER2 FISH negative, IHC 2+ or IHC 1+
tumours.

About DESTINY-Breast01

DESTINY-Breast01 is a pivotal Phase II, open-label, global,
multicentre, two-part trial evaluating the safety and efficacy of
trastuzumab deruxtecan in patients with HER2-positive unresectable
and/or metastatic breast cancer previously treated with trastuzumab
emtansine. The primary endpoint of the trial is objective response
rate, as determined by independent central review. Secondary
objectives include duration of response, disease control rate,
clinical benefit rate, progression-free survival and overall
survival. Enrolment into DESTINY-Breast01 was completed in September
2018 with 253 patients at more than 100 sites across North America,
Europe, Japan and other countries in Asia.

The safety and tolerability profile of trastuzumab deruxtecan in
DESTINY-Breast01 was consistent with the Phase I trial data published
in The Lancet Oncology
(https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30097-X/fulltext),
in which the most common adverse events (?30 percent, any grade)
included nausea, decreased appetite, vomiting, alopecia, fatigue,
anaemia, diarrhoea and constipation. Cases of drug-related
interstitial lung disease and pneumonitis, including grade 5 events,
have also been reported in the clinical development programme.

About trastuzumab deruxtecan

Trastuzumab deruxtecan (DS-8201; [fam-] trastuzumab deruxtecan in US
only; trastuzumab deruxtecan in other regions of world) is the lead
product in the investigational ADC Franchise of the Daiichi Sankyo
Cancer Enterprise and the most advanced programme in AstraZeneca's
ADC scientific platform. ADCs are targeted cancer medicines that
deliver cytotoxic chemotherapy ("payload") to cancer cells via a
linker attached to a monoclonal antibody that binds to a specific
target expressed on cancer cells.

A comprehensive development programme is underway in North America,
Europe and Asia, including five pivotal trials in HER2-expressing
metastatic breast and gastric cancers, including a trial in patients
with metastatic breast cancer and low levels of HER2 expression.
Phase II trials are underway for HER2-expressing advanced colorectal
cancer, as well as metastatic non-squamous HER2-overexpressing or
HER2-mutated non-small cell lung cancer. Trials in combination with
other anticancer treatments, such as immunotherapy, are also
underway.

Regulatory submission of trastuzumab deruxtecan was recently made to
Japan's Ministry of Health, Labour and Welfare (MHLW) for the
treatment of patients with HER2-positive metastatic breast cancer. It
also received SAKIGAKE designation for the treatment of advanced
HER2-positive gastric or gastroesophageal junction cancer by Japan's
MHLW.

About the collaboration between AstraZeneca and Daiichi Sankyo

In March 2019, AstraZeneca and Daiichi Sankyo entered into a global
collaboration to jointly develop and commercialise trastuzumab
deruxtecan as a potential new medicine worldwide, except in Japan
where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo
will be solely responsible for manufacturing and supply in Japan.

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, the Company
is committed to advance oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers. In
addition to AstraZeneca's main capabilities, the Company is actively
pursuing innovative partnerships and investments that accelerate the
delivery of our strategy, as illustrated by the 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 and Metabolism
(CVRM), and Respiratory. AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients
worldwide. For more information, please visit astrazeneca.com
(http://www.astrazeneca.com/) and follow us on Twitter @AstraZeneca
(https://twitter.com/AstraZeneca).

Media Relations
Gonzalo Viña +44 203 749 5916
Rob Skelding Oncology +44 203 749 5821
Rebecca Einhorn Oncology +1 301 518 4122
Matt Kent BioPharmaceuticals +44 203 749 5906
Jennifer Hursit Other +44 203 749 5762
Christina Sweden +46 8 552 53 106
Malmberg
Hägerstrand
Michele Meixell US +1 302 885 2677

Investor
Relations
Thomas Kudsk +44 203 749 5712
Larsen
Henry Wheeler Oncology +44 203 749 5797
Christer BioPharmaceuticals (CV, metabolism) +44 203 749 5711
Gruvris
Nick Stone BioPharmaceuticals (respiratory, renal) +44 203 749 5716
Josie Afolabi Other medicines +44 203 749 5631
Craig Marks Finance, fixed income +44 7881 615 764
Jennifer Corporate access, retail investors +44 203 749 5824
Kretzmann
US toll-free +1 866 381 72 77

References

1. Tamura, K, et al. Trastuzuamb deruxtecan (DS-8201a) in patients
with advanced HER2-positive breast cancer previously treated with
trastuzumab emtansine: a dose-expansion, phase 1 study. Lancet Oncol.
2019;20(6):816-826.

2. American Cancer Society. Breast Cancer HER2 Status. Available at
https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cance....
Accessed August 2019.

3.Tandon A, et al. HER-2/neu Oncogene Protein and Prognosis in Breast
Cancer. J Clin Oncol. 1989;7(8):1120-8.

4. Sledge G, et al. Past, Present, and Future Challenges in Breast
Cancer Treatment. J Clin Oncol. 2014;32(19):1979-1986.

5.de Melo Gagliato D, et al. Mechanisms of Resistance and Sensitivity
to Anti-HER2 Therapies in HER2+ Breast Cancer. Oncotarget.
2016;7(39):64431-46.

6. National Comprehensive Cancer Network (NCCN). NCCN Guidelines.
Breast Cancer. Available at https://nccn.org. Accessed August 2019.

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