Pfizer Inc. today announced the launch of a competitive, peer-reviewed
grants program to support clinical research projects investigating
IBRANCE® (palbociclib) in advanced breast cancer. The multi-year
program, which will award a total of up to $3 million in grants to
investigators in the United States, is an extension of Pfizer’s
Advancing Science through Pfizer Investigator Research Exchange (ASPIRE)
initiative. It is the first ASPIRE program to focus on breast cancer
research.
IBRANCE received accelerated approval by the U.S. Food and Drug
Administration in February 2015 for use in combination with letrozole
for the treatment of postmenopausal women with estrogen
receptor-positive, human epidermal growth factor receptor 2-negative
(ER+/HER2-) advanced breast cancer as initial endocrine-based therapy
for their metastatic disease.
“We believe the ASPIRE Breast Cancer Research Awards will contribute
important information to our body of knowledge about the role IBRANCE
plays in the treatment and clinical management of advanced breast
cancer, and will complement the robust clinical development program we
have ongoing,” said Dr. Julia Perkins Smith, senior medical director,
U.S. Breast Cancer Lead, Pfizer Oncology. “Through these awards, we also
look forward to supporting the mission of the ASPIRE program to further
academic research and nurture the career development of emerging
investigators in a disease area of high unmet medical need.”
“This is an exciting opportunity to gain a better understanding of the
efficacy and tolerability of CDK inhibition in ER+ breast cancer,” said
Dr. Ruth O’Regan, head of hematology and oncology in the Department of
Medicine at the University of Wisconsin School of Medicine and Public
Health.
Grantees will be selected through a competitive application process
overseen by an independent review panel of breast cancer experts.
The review panel encourages investigators (with a special interest for
emerging researchers at Assistant Professor level or equivalent) to
submit applications for innovative research in several areas. Highlights
of the research of interest include:
-
Improving the medical knowledge of palbociclib in the treatment of
advanced breast cancer
-
Optimizing clinical management during palbociclib treatment that
addresses or improves patient compliance and convenience and/or
patient reported outcomes
For more information about the ASPIRE Breast Cancer Research Awards and
specifics regarding eligible areas of research, please visit www.aspireresearch.org.
The application submission period ends September 8, 2015, and successful
awardees will be notified in October. Pfizer anticipates providing up to
six awards to investigators in the United States.
About IBRANCE®
IBRANCE is an oral 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 IBRANCE is indicated in the U.S. for use in
combination with letrozole for the treatment of postmenopausal women
with estrogen receptor-positive, human epidermal growth factor receptor
2-negative (ER+/HER2-) advanced breast cancer as initial endocrine-based
therapy for their metastatic disease. The effectiveness of IBRANCE in
these patients is based on a study that measured progression-free
survival. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory trial.
The full prescribing information for IBRANCE can be found at www.IBRANCE.com.
IBRANCE is not approved for any indication in any market outside the U.S.
Important IBRANCE (palbociclib) Safety 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
May 28, 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) and the ASPIRE program, 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 the PALOMA-2
Phase 3 trial of IBRANCE in combination with letrozole for the treatment
of postmenopausal women with ER+/HER2- advanced breast cancer as initial
endocrine-based therapy for their metastatic disease 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
may be filed in jurisdictions outside the United States for IBRANCE;
whether and when any such 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, 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.
1IBRANCE® (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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