Pfizer Inc. today announced that the European Medicines Agency
(EMA) has validated for review the Marketing Authorization
Application (MAA) for IBRANCE® (palbociclib) in combination with
endocrine therapy for the treatment of hormone receptor-positive,
human epidermal growth factor receptor 2-negative (HR+/HER2-)
advanced or metastatic breast cancer. With this validation, the
Pfizer application is complete and the EMA will now begin the
review procedure.
“The MAA for IBRANCE is based on the results from the PALOMA-1
and PALOMA-3 trials, which demonstrated significant clinical
benefit for women with HR+/HER2- advanced or metastatic breast
cancer,” said Dr. Mace Rothenberg, senior vice president of
Clinical Development and Medical Affairs and chief medical officer
for Pfizer Oncology. “The acceptance of our application for review
by the EMA represents a significant step towards potentially
bringing IBRANCE to women with metastatic breast cancer in Europe,
and Pfizer looks forward to working with the EMA on the review
procedure.”
The submission is based on the final results of the PALOMA-1 and
PALOMA-3 trials in metastatic breast cancer. Both trials
demonstrated that IBRANCE in combination with an endocrine therapy
improved progression-free survival (PFS) compared to endocrine
therapy alone.
The Phase 3 PALOMA-3 study evaluated IBRANCE in combination with
fulvestrant compared to a standard of care, fulvestrant, plus
placebo in women with HR+/HER2- metastatic breast cancer whose
disease had progressed during or after endocrine therapy. The
results were presented as a late-breaker at the 51st Annual Meeting
of the American Society of Clinical Oncology (ASCO) and published
in The New England Journal of Medicine in June 2015. The Phase 2
PALOMA-1 study evaluated IBRANCE in combination with letrozole
compared to letrozole alone in postmenopausal women with estrogen
receptor-positive (ER+)/HER2- locally advanced or metastatic breast
cancer who had not received previous systemic treatment for their
advanced disease. Results were presented in an oral presentation at
the American Association of Cancer Research (AACR) Annual Meeting
and published in The Lancet Oncology in 2014.
About IBRANCE® (palbociclib)
IBRANCE is an oral, first-in-class inhibitor of cyclin-dependent
kinases (CDKs) 4 and 6.1 CDKs 4 and 6 are key regulators of
the cell cycle that trigger cellular progression.2,3
In the European Union, IBRANCE is an investigational agent and
has not been approved.
IBRANCE was approved by the U.S. Food and Drug Administration
(FDA) in February 2015 for use in combination with letrozole as a
treatment for postmenopausal women with ER+/HER2- advanced breast
cancer as initial endocrine-based therapy for their metastatic
disease.1 The effectiveness of IBRANCE in these patients is based
on a study that measured PFS.1 Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in a confirmatory trial. IBRANCE has also received
regulatory approval in Albania, Chile and Macau.
IMPORTANT IBRANCE (palbociclib) SAFETY INFORMATION FROM THE
U.S. PRESCRIBING INFORMATION
Neutropenia: Neutropenia is frequently reported with
IBRANCE therapy. In the randomized phase II study, Grade 3 (57%) or
4 (5%) decreased neutrophil counts were reported in patients
receiving IBRANCE plus letrozole. Febrile neutropenia can
occur.
Monitor complete blood count prior to starting IBRANCE and at
the beginning of each cycle, as well as Day 14 of the first two
cycles, and as clinically indicated. For patients who experience
Grade 3 neutropenia, consider repeating the complete blood count
monitoring 1 week later. Dose interruption, dose reduction, or
delay in starting treatment cycles is recommended for patients who
develop Grade 3 or 4 neutropenia.
Infections: Infections have been reported at a higher
rate in patients treated with IBRANCE plus letrozole (55%) compared
with letrozole alone (34%). Grade 3 or 4 infections occurred in 5%
of patients treated with IBRANCE plus letrozole vs no patients
treated with letrozole alone. Monitor patients for signs and
symptoms of infection and treat as medically appropriate.
Pulmonary embolism (PE): PE has been reported at a higher
rate in patients treated with IBRANCE plus letrozole (5%) compared
with no cases in patients treated with letrozole alone. Monitor
patients for signs and symptoms of PE and treat as medically
appropriate.
Pregnancy and lactation: Based on the mechanism of
action, IBRANCE can cause fetal harm. Advise females with
reproductive potential to use effective contraception during
therapy with IBRANCE and for at least 2 weeks after the last dose.
Advise females to contact their healthcare provider if they become
pregnant or if pregnancy is suspected during treatment with
IBRANCE. Advise women not to breastfeed while on IBRANCE therapy
because of the potential for serious adverse reactions in nursing
infants from IBRANCE.
Additional hematologic abnormalities: Decreases in
hemoglobin (83% vs 40%), leukocytes (95% vs 26%), lymphocytes (81%
vs 35%), and platelets (61% vs 16%) occurred at a higher rate in
patients treated with IBRANCE plus letrozole vs letrozole
alone.
Adverse reactions: The most common all causality adverse
reactions (≥10%) of any grade reported in patients treated with
IBRANCE plus letrozole vs letrozole alone in the phase II study
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 reported (≥10%) occurring at a
higher incidence in the IBRANCE plus letrozole vs letrozole alone
group include neutropenia (54% vs 1%) and leukopenia (19% vs 0%).
The most frequently reported serious adverse events in patients
receiving IBRANCE were pulmonary embolism (4%) and diarrhea
(2%).
General dosing information: The recommended dose of
IBRANCE is 125 mg taken orally once daily for 21 days followed by 7
days off treatment in 28-day cycles. IBRANCE should be taken with
food and in combination with letrozole 2.5 mg once daily
continuously.
Patients should be encouraged to take their dose at
approximately the same time each day.
Capsules should be swallowed whole. No capsule should be
ingested if it is broken, cracked, or otherwise not intact. If a
patient vomits or misses a dose, an additional dose should not be
taken that day. The next prescribed dose should be taken at the
usual time.
Management of some adverse reactions may require temporary dose
interruption/delay and/or dose reduction, or permanent
discontinuation. Dose modification of IBRANCE is recommended based
on individual safety and tolerability.
Drug interactions: 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 and moderate CYP3A inducers. The
dose of the sensitive CYP3A substrates with a narrow therapeutic
index may need to be reduced as IBRANCE may increase their
exposure.
Hepatic and renal impairment: 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 the discovery, investigation and
development of innovative treatment options to improve the outlook
for cancer patients worldwide. Our strong pipeline of biologics and
small molecules, 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 breakthrough medicines, to
deliver the right drug for each patient at the right time. For more
information, please visit www.Pfizer.com.
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, Pfizer has worked to make a difference for
all who rely on us. To learn more, please visit us at
www.pfizer.com.
DISCLOSURE NOTICE: The information contained in this release is
as of August 20, 2015. 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) that involves substantial risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied by such statements. Forward-looking statements
include those about IBRANCE’s potential benefits and about the MAA
for IBRANCE in Europe for a potential indication for the treatment
of women with HR+/HER2- advanced or metastatic breast cancer in
combination with endocrine therapy. 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 the PALOMA-2 Phase 3 trial of
IBRANCE will demonstrate a statistically significant improvement in
progression-free survival and whether the other trials of IBRANCE
will meet their primary endpoints; whether regulatory authorities
will be satisfied with the design of and results from our clinical
studies; whether and when drug applications or supplemental drug
applications may be filed with the U.S. Food and Drug
Administration or any other jurisdictions for potential HR+/HER2-
metastatic breast cancer indications for IBRANCE; whether and when
the EMA may approve the MAA and whether and when any other
applications may be approved by other 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, 2014 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 SEC and available at www.sec.gov
and www.pfizer.com.
1 IBRANCE® (palbociclib) Prescribing Information. New York. NY:
Pfizer Inc: 2015.
2 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.
3 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:Sally Beatty, 212-733-6566orInvestor:Ryan
Crowe, 212-733-8160
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