Positive opinion based on results from largest
Phase 3 trial performed to date of a PARP inhibitor in
gBRCA-mutated advanced breast cancer
Pfizer Inc. (NYSE: PFE) today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) adopted a positive opinion recommending TALZENNA®
(talazoparib), an oral poly (ADP-ribose) polymerase (PARP)
inhibitor, be granted marketing authorization in the European Union
(EU). The indication the CHMP adopted is for TALZENNA as
monotherapy for the treatment of adult patients with germline
breast cancer susceptibility gene (gBRCA)1/2-mutations, who have
human epidermal growth factor receptor 2-negative (HER2-) locally
advanced (LA) or metastatic breast cancer (MBC). Patients should
have been previously treated with an anthracycline and/or a taxane
in the (neo)adjuvant, locally advanced or metastatic setting unless
patients were not suitable for these treatments. Patients with
hormone receptor-positive (HR+) breast cancer should have been
treated with a prior endocrine-based therapy, or be considered
unsuitable for endocrine-based therapy.
The positive CHMP opinion of TALZENNA follows the medicine’s
approval by the U.S. Food and Drug Administration (FDA) in October
2018.1
“There is a pressing need for new, effective medicines that are
specifically developed for patients with an inherited BRCA mutation
who are often diagnosed at a younger age and have limited options
for the treatment of advanced-stage disease,” said Chris Boshoff,
M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global
Product Development. “Results from the EMBRACA trial provide
evidence supporting the use of TALZENNA in these patients, and we
look forward to working with the European Commission to potentially
offer an alternative treatment option to chemotherapy.”
The CHMP’s opinion for TALZENNA, which was acquired as part of
Pfizer’s acquisition of Medivation, will now be reviewed by the
European Commission. The Marketing Authorization Application was
submitted based on results from the EMBRACA trial, the largest
Phase 3 trial performed to date of a PARP inhibitor in patients
with gBRCA-mutated LA or MBC. This Phase 3, open-label, randomized
trial evaluated once-daily TALZENNA compared to physician’s choice
standard chemotherapy (capecitabine, eribulin, gemcitabine or
vinorelbine) in patients with an inherited BRCA1/2 mutation and
triple-negative or HR+/HER2- LA or MBC who may have received up to
three prior cytotoxic chemotherapy regimens for their advanced
disease. A total of 431 patients were enrolled at 145 sites in 16
countries, including 190 patients in European countries such as
Belgium, France, Germany, Ireland, Italy, Poland, Spain and the
United Kingdom.
About talazoparib
Talazoparib is an inhibitor of PARP enzymes, which play a role
in DNA repair. Preclinical studies suggest that talazoparib may
work by blocking PARP enzyme activity and trapping PARP at the site
of DNA damage, leading to decreased cancer cell growth and cancer
cell death. Talazoparib anti-tumor activity also was observed in
mouse models of human breast cancer that expressed mutated or
non-mutated BRCA1/2.1
In addition to gBRCA-mutated LA or MBC, talazoparib also is
being evaluated in several ongoing clinical trials in breast and
other cancers, including early triple-negative breast cancer and
prostate cancer, as well as other novel combinations with targeted
therapies and studies with immunotherapy in various solid
tumors.
Indication in the U.S.
TALZENNA® (talazoparib) is approved in the U.S. for the
treatment of adult patients with deleterious or suspected
deleterious germline breast cancer susceptibility gene
(gBRCA)-mutated human epidermal growth factor receptor 2-negative
(HER2-), locally advanced or metastatic breast cancer. Select
patients for therapy based on an FDA-approved companion diagnostic
for TALZENNA.1
TALZENNA® (talazoparib) Important Safety
Information from the U.S. Prescribing Information
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML)
have been reported in patients who received TALZENNA. Overall,
MDS/AML have been reported in 2 out of 584 (0.3%) solid tumor
patients treated with TALZENNA in clinical studies.
Myelosuppression consisting of anemia,
leukopenia/neutropenia, and/or thrombocytopenia have been reported
in patients treated with TALZENNA. Grade ≥3 anemia, neutropenia,
and thrombocytopenia were reported, respectively, in 39%, 21%, and
15% of patients receiving TALZENNA. Discontinuation due to anemia,
neutropenia, and thrombocytopenia occurred, respectively, in 0.7%,
0.3%, and 0.3% of patients.
Monitor complete blood counts for cytopenia at baseline
and monthly thereafter. Do not start TALZENNA until patients have
adequately recovered from hematological toxicity caused by previous
therapy. If hematological toxicity occurs, dose modifications
(dosing interruption with or without dose reduction) are
recommended. With respect to MDS/AML, for prolonged
hematological toxicities, interrupt TALZENNA and monitor blood
counts weekly until recovery. If the levels have not recovered
after 4 weeks, refer the patient to a hematologist for further
investigations. If MDS/AML is confirmed, discontinue TALZENNA.
TALZENNA can cause fetal harm when administered to
pregnant women. Advise women of reproductive potential to use
effective contraception during treatment and for at least 7 months
following the last dose. A pregnancy test is recommended for
females of reproductive potential prior to initiating TALZENNA
treatment. Advise male patients with female partners of
reproductive potential or who are pregnant to use effective
contraception during treatment with TALZENNA and for at least
4 months after receiving the last dose. Based on animal
studies, TALZENNA may impair fertility in males of reproductive
potential. Advise women not to breastfeed while taking TALZENNA and
for at least 1 month after receiving the last dose because of the
potential for serious adverse reactions in nursing infants.
The most common adverse reactions (≥20%) of any grade for
TALZENNA vs chemotherapy were fatigue (62% vs 50%), anemia (53% vs
18%), nausea (49% vs 47%), neutropenia (35% vs 43%), headache (33%
vs 22%), thrombocytopenia (27% vs 7%), vomiting (25% vs 23%),
alopecia (25% vs 28%), diarrhea (22% vs 26%), and decreased
appetite (21% vs 22%).
The most frequently reported Grade ≥3 adverse
reactions (≥5%) for TALZENNA vs chemotherapy were anemia (39%
vs 5%), neutropenia (21% vs 36%), and thrombocytopenia (15% vs
2%).
The most common lab abnormalities (≥25%) for TALZENNA vs
chemotherapy were decreases in hemoglobin (90% vs 77%), leukocytes
(84% vs 73%), lymphocytes (76% vs 53%), neutrophils (68% vs 70%),
platelets (55% vs 29%), and calcium (28% vs 16%) and increases in
glucose (54% vs 51%), aspartate aminotransferase (37% vs 48%),
alkaline phosphatase (36% vs 34%), and alanine aminotransferase
(33% vs 37%).
Coadministration with P-gp inhibitors or BCRP
inhibitors may increase TALZENNA exposure. If coadministering
with the P-gp inhibitors amiodarone, carvedilol, clarithromycin,
itraconazole, or verapamil is unavoidable, reduce the TALZENNA dose
to 0.75 mg once daily. When the P-gp inhibitor is discontinued,
increase the TALZENNA dose (after 3–5 half-lives of the P-gp
inhibitor) to the dose used prior to the initiation of the P-gp
inhibitor. When co-administering TALZENNA with other known P-gp
inhibitors or BCRP inhibitors, monitor patients for potential
increased adverse reactions.
For patients with moderate renal impairment, the
recommended dose of TALZENNA is 0.75 mg once daily. No dose
adjustment is required for patients with mild renal impairment.
TALZENNA has not been studied in patients with severe renal
impairment or in patients requiring hemodialysis.
TALZENNA has not been studied in patients with moderate or
severe hepatic impairment. No dose adjustment is required
for patients with mild hepatic impairment.
Please see full U.S. Prescribing Information and Patient
Information for TALZENNA® (talazoparib) at www.TALZENNA.com.
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines
wherever we believe we can make a meaningful difference in the
lives of patients. Today, Pfizer Oncology has an industry-leading
portfolio of 18 approved innovative cancer medicines and
biosimilars across more than 20 indications, including breast,
prostate, kidney, lung and hematology. Pfizer Oncology is striving
to change the trajectory of 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
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DISCLOSURE NOTICE: The information contained in this release is
as of April 26, 2019. 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 TALZENNA
(talazoparib), including a potential indication in the EU and
TALZENNA’s potential benefits, that involve 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, uncertainties regarding
the commercial success of TALZENNA; the uncertainties inherent in
research and development, including the ability to meet anticipated
clinical endpoints, commencement and/or completion dates for our
clinical trials, regulatory submission dates, regulatory approval
dates and/or launch dates, as well as the possibility of
unfavorable new clinical data and further analyses of existing
clinical data; the risk that clinical trial data are subject to
differing interpretations and assessments by regulatory
authorities; whether regulatory authorities will be satisfied with
the design of and results from our clinical studies; whether and
when applications for TALZENNA may be filed in any other
jurisdictions; whether and when the European Commission may approve
the pending application for TALZENNA in the EU and whether and when
any such other applications for TALZENNA that may be pending or
filed may be approved by regulatory authorities, which will depend
on myriad factors, including making a determination as to whether
the product’s benefits outweigh its known risks and determination
of the product’s efficacy and, if approved, whether TALZENNA will
be commercially successful; decisions by regulatory authorities
impacting labeling, manufacturing processes, safety and/or other
matters that could affect the availability or commercial potential
of TALZENNA; 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, 2018 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 TALZENNA® (talazoparib) Prescribing Information. New York. NY:
Pfizer Inc: 2018.
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Pfizer Media Contact:Sally Beatty (U.S.)(347)
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Pfizer Investor Contact:Ryan Crowe(212)
733-8160Ryan.Crowe@pfizer.com
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