NEW YORK–(BUSINESS WIRE)– 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 all who
rely on us. For more information, please visit us at www.pfizer.com.
In addition, to learn more, follow us on Twitter at @Pfizer
and @Pfizer_News,
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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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Contacts
Pfizer Inc.
Media:
Europe
Lisa O’Neill, +44.1737.331536
or
U.S.
Sally
Beatty, 212-733-6566
or
Investors:
Ryan Crowe,
212-733-8160
Source: Pfizer Inc.
Cet article Pfizer Receives Positive CHMP Opinion For IBRANCE®
(palbociclib) In Combination With Endocrine Therapy For The Treatment Of
HR+/HER2- Metastatic Breast Cancer In Europe est apparu en premier sur EEI-BIOTECHFINANCES.