TIDMAZN
RNS Number : 1963Q
AstraZeneca PLC
17 October 2019
17 Oct 2019 07:00 BST
Trastuzumab deruxtecan granted FDA Priority Review for
treatment of patients with HER2-positive metastatic breast
cancer
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 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, 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 and follow us on Twitter @AstraZeneca.
Media Relations
Gonzalo Viña +44 203 749 5916
Rob Skelding Oncology +44 203 749 5821
Rebecca Einhorn Oncology +1 301 518 4122
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Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Henry Wheeler Oncology +44 203 749 5797
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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-cancer-diagnosis/breast-cancer-her2-status.html.
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.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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END
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