Pfizer Inc.
(NYSE: PFE) today announced that the U.S. Patent and Trademark Office (USPTO)
recently issued a U.S. Patent Term Extension (PTE) certificate for IBRANCE®
(palbociclib). The certificate extends the term of U.S. Patent No. RE47,739
(‘739) by more than four years until March 5, 2027. The PTE certificate was
granted under the patent restoration provisions of the Drug Price Competition
and Patent Term Restoration Act of 1984.
This PTE
will be listed in Approved Drug Products with Therapeutic Equivalence
Evaluations (commonly known as the Orange Book), published by the U.S. Food and
Drug Administration (FDA). This extension does not include potential pediatric
exclusivity.
About
IBRANCE® (palbociclib) 125 mg tablets and capsules
IBRANCE is
an oral inhibitor of CDKs 4 and 6,1 which are key regulators of the cell cycle
that trigger cellular progression.2,3 In the U.S., IBRANCE is indicated for the
treatment of adult patients with HR+, HER2- advanced or metastatic breast
cancer in combination with an aromatase inhibitor as initial endocrine based
therapy in postmenopausal women or in men; or with fulvestrant in patients with
disease progression following endocrine therapy.
IBRANCE is
currently approved in more than 100 countries and has been prescribed to more
than 350,000 patients globally.
The full
U.S. Prescribing Information for the IBRANCE tablets and the IBRANCE capsules
can be found here and here.
IMPORTANT
IBRANCE® (palbociclib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION
Neutropenia
was the most frequently reported adverse reaction in PALOMA-2 (80%) and
PALOMA-3 (83%). In PALOMA-2, Grade 3 (56%) or 4 (10%) decreased neutrophil
counts were reported in patients receiving IBRANCE plus letrozole. In PALOMA-3,
Grade 3 (55%) or Grade 4 (11%) decreased neutrophil counts were reported in
patients receiving IBRANCE plus fulvestrant. Febrile neutropenia has been
reported in 1.8% of patients exposed to IBRANCE across PALOMA-2 and PALOMA-3.
One death due to neutropenic sepsis was observed in PALOMA-3. Inform patients
to promptly report any fever.
Monitor
complete blood count prior to starting IBRANCE, at the beginning of each cycle,
on Day 15 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.
Severe,
life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis
can occur in patients treated with CDK4/6 inhibitors, including IBRANCE when
taken in combination with endocrine therapy. Across clinical trials (PALOMA-1,
PALOMA-2, PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of
any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported. Additional
cases of ILD/pneumonitis have been observed in the post-marketing setting, with
fatalities reported.
Monitor
patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia,
cough, dyspnea). In patients who have new or worsening respiratory symptoms and
are suspected to have developed pneumonitis, interrupt IBRANCE immediately and
evaluate the patient. Permanently discontinue IBRANCE in patients with severe
ILD or pneumonitis.
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 to
consider sperm preservation before taking IBRANCE. 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 PALOMA-2 for IBRANCE
plus letrozole vs placebo plus letrozole were neutropenia (80% vs 6%),
infections (60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea
(35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26% vs
19%), anemia (24% vs 9%), rash (18% vs 12%), asthenia (17% vs 12%),
thrombocytopenia (16% vs 1%), vomiting (16% vs 17%), decreased appetite (15% vs
9%), dry skin (12% vs 6%), pyrexia (12% vs 9%), and dysgeusia (10% vs 5%).
The most
frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-2 for IBRANCE
plus letrozole vs placebo plus letrozole were neutropenia (66% vs 2%),
leukopenia (25% vs 0%), infections (7% vs 3%), and anemia (5% vs 2%).
Lab
abnormalities of any grade occurring in PALOMA-2 for IBRANCE plus letrozole vs
placebo plus letrozole were decreased WBC (97% vs 25%), decreased neutrophils
(95% vs 20%), anemia (78% vs 42%), decreased platelets (63% vs 14%), increased
aspartate aminotransferase (52% vs 34%), and increased alanine aminotransferase
(43% vs 30%).
The most
common adverse reactions (≥10%) of any grade reported in PALOMA-3 for IBRANCE
plus fulvestrant vs placebo plus fulvestrant were 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%), diarrhea (24% vs
19%), thrombocytopenia (23% vs 0%), vomiting (19% vs 15%), alopecia (18% vs
6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).
The most
frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-3 for IBRANCE
plus fulvestrant vs placebo plus fulvestrant were neutropenia (66% vs 1%) and
leukopenia (31% vs 2%).
Lab
abnormalities of any grade occurring in PALOMA-3 for IBRANCE plus fulvestrant
vs placebo plus fulvestrant were decreased WBC (99% vs 26%), decreased
neutrophils (96% vs 14%), anemia (78% vs 40%), decreased platelets (62% vs
10%), increased aspartate aminotransferase (43% vs 48%), and increased alanine
aminotransferase (36% vs 34%).
Avoid
concurrent use of strong CYP3A inhibitors. If patients must be administered a
strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg. 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.
For
patients with severe hepatic impairment (Child-Pugh class C), the recommended
dose of IBRANCE is 75 mg. The pharmacokinetics of IBRANCE have not been studied
in patients requiring hemodialysis.
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 people living with cancer. Today,
we have an industry-leading portfolio of 24 approved innovative cancer
medicines and biosimilars across more than 30 indications, including breast,
genitourinary, colorectal, blood and lung cancers, as well as melanoma.
About Pfizer:
Breakthroughs That Change Patients’ Lives
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, including innovative medicines and vaccines. 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 170 years, we
have worked to make a difference for all who rely on us. We routinely post
information that may be important to investors on our website at
www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com
and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and
like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE
NOTICE: The information contained in this release is as of February 5, 2021.
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),
including its potential benefits, the U.S. Patent Term Extension certificate
for IBRANCE and potential pediatric exclusivity for IBRANCE, 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 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 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 any such other applications 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 such product candidates 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 IBRANCE; uncertainties
regarding the impact of COVID-19 on Pfizer’s business, operations and financial
results; 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, 2019 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.
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