U.S. New Drug Application Granted FDA Priority
Review
Submissions Based on Data from EMBRACA, the
Largest Phase 3 Trial Performed to Date of a PARP Inhibitor in
BRCA-mutated MBC
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and
Drug Administration accepted for filing and granted Priority Review
designation to the company’s New Drug Application for talazoparib.
The submission is based on results from the EMBRACA trial, which
evaluated talazoparib versus chemotherapy in patients with germline
(inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced
or metastatic breast cancer (MBC). Talazoparib is an
investigational, once-daily, oral poly ADP ribose polymerase (PARP)
inhibitor. The European Medicines Agency has also accepted the
Marketing Authorization Application for talazoparib in this patient
population.
“Women with a hereditary BRCA mutation are typically diagnosed
with breast cancer at a younger age than the overall breast cancer
population and have limited treatment options when they develop
advanced disease,” said Mace Rothenberg, M.D., chief development
officer, Oncology, Pfizer Global Product Development. “Today’s
filing acceptances are just the latest example of the success of
Pfizer’s precision medicine approach to drug development, in this
case targeting the faulty DNA damage repair process associated with
BRCA mutations. We are now one step closer to offering a potential
alternative to chemotherapy for these patients.”
The FDA grants Priority Review designation to medicines that may
offer significant advances in treatment or may provide a treatment
where no adequate therapy exists. The Prescription Drug User Fee
Act (PDUFA) goal date for a decision by the FDA is in December
2018.
The pivotal, randomized EMBRACA trial evaluated once-daily
talazoparib compared to physician’s choice chemotherapy
(capecitibine, eribulin, gemcitabine or vinorelbine) in 431
patients with an inherited BRCA1/2 mutation and locally advanced or
metastatic triple negative (TNBC) or hormone receptor-positive
(HR+)/HER2- breast cancer. The study met its primary endpoint,
demonstrating superior progression-free survival (PFS) with
talazoparib versus chemotherapy. The PFS benefit was consistent
across prespecified subgroups, including those who had a history of
brain metastases, patients previously treated with chemotherapy,
TNBC patients and those with HR+ disease. Grade ≥3 adverse
reactions with talazoparib that occurred with a frequency of at
least 10% were anemia (35%), neutropenia (17%) and thrombocytopenia
(17%). The primary results were presented at the 2017 San Antonio
Breast Cancer Symposium. For more information on the EMBRACA trial,
go to www.clinicaltrials.gov.
About Talazoparib
Talazoparib is an investigational anti-cancer medicine called a
PARP (poly ADP ribose polymerase) inhibitor. Preclinical studies
suggest that talazoparib is highly potent and has a dual mechanism
of action, with the potential to induce tumor cell death by
blocking PARP enzyme activity and trapping PARP on the sites of DNA
damage. Talazoparib is currently being evaluated in advanced gBRCAm
breast cancer and early triple negative breast cancer as well as
DNA damage repair (DDR)-deficient prostate cancer and in
combination with immunotherapy in various solid tumor types.
Talazoparib has not been approved by any regulatory authorities for
the treatment of any disease.
About Germline (Inherited) BRCA-Mutated Breast Cancer
BRCA1 and BRCA2 are human genes that produce proteins involved
in DNA repair. When either of these genes is altered or mutated,
DNA repair may not progress correctly. This can lead to the
development of certain types of cancer such as breast cancer.1,2,3
BRCA mutations can be hereditary (germline) or occur spontaneously
(somatic).1 Together, BRCA1 and BRCA2 mutations account for about
25 to 30 percent of hereditary breast cancers and about 5 to 10
percent of all breast cancers.4,5 It is estimated that about 72
percent of people who inherit a BRCA1 mutation and about 69 percent
who inherit a BRCA2 mutation will develop breast cancer by age 80.1
Epidemiologic studies indicate that individuals with gBRCAm breast
cancer are diagnosed at a median age of 40-45, which is
approximately 20 years younger than the overall breast cancer
population.6
BRCA-mutated breast cancer is considered metastatic if it has
spread beyond the breast to other parts of the body, including the
bones, liver, lung or brain. There is currently no cure for
metastatic breast cancer, the most advanced stage (stage IV) of the
disease. The goal of treatment is to delay or slow disease
progression while maintaining quality of life.7
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments
that have a meaningful impact on people living with cancer. Our
growing pipeline of biologics, small molecules and immunotherapies
is focused on identifying and translating the best scientific
breakthroughs into clinical application for patients across a
diverse array of solid tumors and hematologic cancers. Today, we
have 10 approved oncology medicines and 14 assets currently in
clinical development. By maximizing our internal scientific
resources and collaborating with other companies, government and
academic institutions, as well as patients and non-profit and
professional organizations, we are bringing together the brightest
and most enterprising minds to take on the toughest cancers.
Together we can accelerate breakthrough treatments to patients
around the world and work to redefine life with cancer.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
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addition, to learn more, please visit us on www.pfizer.com and
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DISCLOSURE NOTICE: The information contained in this release is
as of June 7, 2018. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or developments.
This release contains forward-looking information about a
product candidate, talazoparib, and Pfizer’s oncology portfolio,
including their potential benefits, that involves substantial risks
and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical trial commencement and
completion dates and regulatory submission dates, as well as the
possibility of unfavorable clinical trial results, including
unfavorable new clinical data and additional analyses of existing
clinical data; the risk that clinical trial data are subject to
differing interpretations, and, even when we view data as
sufficient to support the safety and/or effectiveness of a product
candidate, regulatory authorities may not share our views and may
require additional data or may deny approval altogether; whether
regulatory authorities will be satisfied with the design of and
results from our clinical studies; whether and when new drug
applications may be filed in any other jurisdictions for
talazoparib or any other oncology products; whether and when the
applications for talazoparib pending with the FDA and the European
Medicines Agency or any such other applications that may be pending
or filed may be approved by regulatory authorities, which will
depend on the assessment by such regulatory authorities of the
benefit-risk profile suggested by the totality of the efficacy and
safety information submitted, and, if approved, whether talazoparib
or any such other oncology products will be commercially
successful; decisions by regulatory authorities regarding labeling
and other matters that could affect the availability or commercial
potential of talazoparib or other oncology products; and
competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2017 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
__________________________
1 National Cancer Institute. BRCA
mutations: Cancer risk and genetic testing.
https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet.
Accessed April 30, 2018.
2 Evers B, Schut E, van der Burg E, et al.
A high throughput pharmaceutical screen identifies compounds with
specific toxicity against BRCA2-deficient tumors. Clin Cancer Res.
2010 Jan 1; 16(1): 99–108.
3 Livraghi L, Garber J. PARP inhibitors in
the management of breast cancer: Current data and future prospects.
BMC Medicine. 2015;13:188.
4 Kleibl Z, Kristensen VN. Women at high
risk of breast cancer: molecular characteristics, clinical
presentation and management. The Breast. 2016;28:136-144.
5 Arpino G, Pensabene M, Condello C, et
al. Tumor characteristics and prognosis in familial breast cancer.
BMC Cancer. 2016;16(1):924.
6 Kim R, Peterson A, Isherwood A. et al. Incidence of germline
BRCA1- and BRCA2-mutated breast cancer in the United States. San
Antonio Breast Cancer Symposium. 2016.
7 Smith I. Goals of treatment for patients
with metastatic breast cancer. Semin Oncol. 2006 Feb; 33(1 Suppl
2): S2-5.
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version on businesswire.com: https://www.businesswire.com/news/home/20180607005223/en/
Pfizer Media:Jessica Smith, (212)
733-6213Jessica.M.Smith@pfizer.comorPfizer Investor:Ryan Crowe,
(212) 733-8160Ryan.Crowe@pfizer.com
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