Pfizer Inc. (NYSE:PFE) today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has adopted a positive opinion recommending that
IBRANCE® (palbociclib) be granted marketing authorization in the
European Union (EU) for the treatment of women with hormone
receptor-positive, human epidermal growth factor receptor
2-negative (HR+/HER2-) locally advanced or metastatic breast
cancer. The CHMP’s positive opinion is for IBRANCE to be used in
combination with an aromatase inhibitor, as well as in combination
with fulvestrant in women who have received prior endocrine
therapy. The CHMP’s opinion will now be reviewed by the European
Commission (EC).
If approved, IBRANCE would be the first medicine in a new class
of anti-cancer treatments, cyclin-dependent kinase 4/6 (CDK 4/6)
inhibitors, to be approved by the EC.
“Today’s opinion by the CHMP to recommend marketing
authorization of IBRANCE in the EU is an important step toward
expanding treatment options for women in Europe with HR+/HER2-
metastatic breast cancer, and a step toward a potential new
standard of care for this cancer,” said Mace Rothenberg, M.D.,
chief development officer, Pfizer Oncology. “The opinion is
supported by robust data with consistent results observed across
three separate randomized trials in which the addition of IBRANCE
to standard endocrine therapy resulted in significant prolongation
of progression-free survival compared to endocrine therapy
alone.”
“There have been only modest improvements in the prognosis of
patients with metastatic breast cancer in Europe over the past
three decades, underscoring the need for new treatment advances,”
said Andreas Penk, M.D., regional president, International
Developed Markets, Pfizer Oncology. “We look forward to working
with the EC as they conduct their review, with the goal of bringing
this first-in-class medicine to appropriate patients across the
EU.”
Breast cancer is the most common invasive cancer among women in
Europe, with more than 464,200 new cases and 131,260 deaths per
year.1 Up to 30 percent of women diagnosed with and treated for
early breast cancer will go on to develop metastatic breast
cancer,2,3 which occurs when the cancer spreads beyond the breast
to other parts of the body.4 There is no cure for metastatic breast
cancer,5 and patients are in need of new treatment options that
help keep their cancer from worsening, manage symptoms and help
them maintain quality of life for as long as possible.2,4
Pfizer announced last year that the EMA validated for review the
Marketing Authorization Application (MAA) for IBRANCE, which was
submitted based on final results from the Phase 2 PALOMA-1 and
Phase 3 PALOMA-3 trials. These studies demonstrated that IBRANCE in
combination with an endocrine therapy improved progression-free
survival (PFS) compared to the endocrine therapy alone or with
placebo in certain patients with HR+/HER2- metastatic breast
cancer. Results from a separate Phase 3 trial, PALOMA-2, conducted
in the same patient population as the Phase 2 PALOMA-1 trial, also
demonstrated an improvement in PFS and were added during the MAA
review.
About IBRANCE® (palbociclib)
IBRANCE is an oral inhibitor of cyclin dependent kinases (CDKs)
4 and 6,6 which are key regulators of the cell cycle that trigger
cellular progression.7,8
In the European Union, IBRANCE is an investigational agent and
has not been approved.
IBRANCE is approved by the U.S. Food and Drug Administration
(FDA) for the treatment of HR+/HER2- advanced or metastatic breast
cancer in combination with letrozole as initial endocrine based
therapy in postmenopausal women, or fulvestrant in women with
disease progression following endocrine therapy.6 The indication in
combination with letrozole is approved in the U.S. under
accelerated approval based on progression-free survival (PFS).
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial.6 Outside of the U.S., IBRANCE has received regulatory
approval in 19 countries to date.
IMPORTANT IBRANCE (palbociclib) SAFETY INFORMATION FROM THE
U.S. PRESCRIBING INFORMATION
Neutropenia was the most frequently reported adverse
reaction in Study 1 (PALOMA-1) (75%) and Study 2 (PALOMA-3) (83%).
In Study 1, Grade 3 (57%) or 4 (5%) decreased neutrophil counts
were reported in patients receiving IBRANCE plus letrozole. In
Study 2, Grade 3 (56%) or Grade 4 (11%) decreased neutrophil counts
were reported in patients receiving IBRANCE plus fulvestrant.
Febrile neutropenia has been reported in about 1% of patients
exposed to IBRANCE. One death due to neutropenic sepsis was
observed in Study 2. Inform patients to promptly report any
fever.
Monitor complete blood count prior to starting IBRANCE, at the
beginning of each cycle, on Day 14 of first 2 cycles, and as
clinically indicated. Dose interruption, dose reduction, or delay
in starting treatment cycles is recommended for patients who
develop Grade 3 or 4 neutropenia.
Pulmonary embolism (PE) has been reported at a
higher rate in patients treated with IBRANCE plus letrozole in
Study 1 (5%) and in patients treated with IBRANCE plus fulvestrant
in Study 2 (1%) compared with no cases in patients treated either
with letrozole alone or fulvestrant plus placebo. Monitor for signs
and symptoms of PE and treat as medically appropriate.
Based on the mechanism of action, IBRANCE can
cause fetal harm. Advise females of reproductive
potential to use effective contraception during IBRANCE treatment
and for at least 3 weeks after the last dose. IBRANCE
may impair fertility in males and has the
potential to cause genotoxicity. Advise male patients with female
partners of reproductive potential to use effective contraception
during IBRANCE treatment and for 3 months after the last dose.
Advise females to inform their healthcare provider of a known or
suspected pregnancy. Advise women not to
breastfeed during IBRANCE treatment and for 3 weeks after
the last dose because of the potential for serious adverse
reactions in nursing infants.
The most common adverse
reactions (≥10%) of any grade reported
in Study 1 of IBRANCE plus letrozole vs letrozole
alone included neutropenia (75% vs 5%), leukopenia (43% vs 3%),
fatigue (41% vs 23%), anemia (35% vs 7%), upper respiratory
infection (31% vs 18%), nausea (25% vs 13%), stomatitis (25% vs
7%), alopecia (22% vs 3%), diarrhea (21% vs 10%), thrombocytopenia
(17% vs 1%), decreased appetite (16% vs 7%), vomiting (15% vs 4%),
asthenia (13% vs 4%), peripheral neuropathy (13% vs 5%), and
epistaxis (11% vs 1%).
Grade 3/4 adverse reactions (≥10%) in Study
1 reported at a higher incidence in the IBRANCE plus
letrozole group vs the letrozole alone group included neutropenia
(54% vs 1%) and leukopenia (19% vs 0%). The most frequently
reported serious adverse events in patients receiving IBRANCE plus
letrozole were pulmonary embolism (4%) and diarrhea (2%).
Lab abnormalities occurring in Study
1 (all grades, IBRANCE plus letrozole vs letrozole alone)
were decreased WBC (95% vs 26%), decreased neutrophils (94% vs
17%), decreased lymphocytes (81% vs 35%), decreased hemoglobin (83%
vs 40%), and decreased platelets (61% vs 16%).
The most common adverse reactions (≥10%) of any
grade reported in Study 2 of IBRANCE plus
fulvestrant vs fulvestrant plus placebo included neutropenia (83%
vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue
(41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis
(28% vs 13%), headache (26% vs 20%), diarrhea (24% vs 19%),
thrombocytopenia (23% vs 0%), constipation (20% vs 16%), vomiting
(19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased
appetite (16% vs 8%), and pyrexia (13% vs 5%).
Grade 3/4 adverse reactions (≥10%) in Study
2 reported at a higher incidence in the IBRANCE plus
fulvestrant group vs the fulvestrant plus placebo group included
neutropenia (66% vs 1%) and leukopenia (31% vs 2%). The most
frequently reported serious adverse reactions in patients receiving
IBRANCE plus fulvestrant were infections (3%), pyrexia (1%),
neutropenia (1%), and pulmonary embolism (1%).
Lab abnormalities occurring in Study
2 (all grades, IBRANCE plus fulvestrant vs fulvestrant
plus placebo) were decreased WBC (99% vs 26%), decreased
neutrophils (96% vs 14%), anemia (78% vs 40%), and decreased
platelets (62% vs 10%).
Avoid concurrent use of strong CYP3A inhibitors. If
patients must be administered a strong CYP3A inhibitor, reduce the
IBRANCE dose to 75 mg/day. If the strong inhibitor is discontinued,
increase the IBRANCE dose (after 3-5 half-lives of the inhibitor)
to the dose used prior to the initiation of the strong CYP3A
inhibitor. Grapefruit or grapefruit juice may increase plasma
concentrations of IBRANCE and should be avoided. Avoid concomitant
use of strong CYP3A inducers. The dose
of sensitive CYP3A substrates with a narrow
therapeutic index may need to be reduced as IBRANCE may increase
their exposure.
IBRANCE has not been studied in patients
with moderate to severe hepatic impairment or in
patients with severe renal impairment (CrCl <30
mL/min).
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments
that have a meaningful impact on those living with cancer. As a
leader in oncology speeding cures and accessible breakthrough
medicines to patients, Pfizer Oncology is helping to redefine life
with cancer. Our strong pipeline of biologics, small molecules and
immunotherapies, one of the most robust in the industry, is studied
with precise focus on identifying and translating the best
scientific breakthroughs into clinical application for patients
across a wide range of cancers. By working collaboratively with
academic institutions, individual researchers, cooperative research
groups, governments and licensing partners, Pfizer Oncology strives
to cure or control cancer with its breakthrough medicines. Because
Pfizer Oncology knows that success in oncology is not measured
solely by the medicines you manufacture, but rather by the
meaningful partnerships you make to have a more positive impact on
people’s lives.
Pfizer Inc.: Working together for a healthier
worldTM
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 healthcare
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer healthcare
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, Pfizer has worked to make a difference for
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Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is
as of September 16, 2016. 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 IBRANCE
(palbociclib) and the MAA in Europe for a potential indication for
the treatment of HR+/HER2- locally advanced or metastatic breast
cancer, 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,
uncertainties regarding the commercial success of IBRANCE; the
uncertainties inherent in research and development, including
further investigation of the clinical benefit of IBRANCE, 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; whether regulatory authorities will be satisfied
with the design of and results from our clinical studies; whether
and when the accelerated approval for IBRANCE will be converted to
regular approval in the U.S.; whether and when drug applications
may be filed in any additional jurisdictions for IBRANCE for
potential HR+/HER2- metastatic breast cancer indications or in
any jurisdictions for any other potential indications for IBRANCE;
whether and when the MAA filed by Pfizer with the EMA for IBRANCE
may be approved and whether and when any such other applications
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; decisions by regulatory authorities
regarding labeling and other matters that could affect the
availability or commercial potential of IBRANCE; 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, 2015 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 (link is external) and
www.pfizer.com.
________________________1 Stewart B, Wild C. International
Agency for Research on Cancer, World Health Organization. World
Cancer Report, 2014.2 O'Shaughnessy J. Extending survival with
chemotherapy in metastatic breast cancer. Oncologist.
2005;10:20-29.3 Dowsett M, et al. Early Breast Cancer Trialists’
Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen
in early breast cancer: patient-level meta-analysis of the
randomised trials. Lancet. 2015;386(10001):1341-1352.4 American
Cancer Society. Detailed Guide: Breast Cancer.
http://www.cancer.org/acs/groups/cid/documents/webcontent/003090-pdf.pdf.
Accessed February 2016.5 Cardoso F, et al. ESO-ESMO 2nd
international consensus guidelines for advanced breast cancer
(ABC2). The Breast 2014;23:489-502.6 IBRANCE® (palbociclib)
Prescribing Information. New York. NY: Pfizer Inc: 2015.7 Weinberg
RA. pRb and Control of the Cell Cycle Clock. In: Weinberg RA, ed.
The Biology of Cancer. 2nd ed. New York, NY: Garland Science;
2014:275-329.8 Sotillo E, Grana X. Escape from Cellular Quiescence.
In: Enders GH, ed. Cell Cycle Deregulation in Cancer. New York, NY:
Humana Press; 2010:3-22.
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Pfizer Inc.Media:EuropeLisa O’Neill, +44.1737.331536orU.S.Sally
Beatty, 212-733-6566orInvestors:Ryan Crowe, 212-733-8160
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