NEW YORK--(BUSINESS WIRE)--
Pfizer today announced that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a
positive opinion recommending Vizimpro® (dacomitinib) 45 mg, as
monotherapy, be granted marketing authorization in the European Union
(EU) for the first-line treatment of adult patients with locally
advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal
growth factor receptor (EGFR)-activating mutations. The CHMP’s opinion
will now be reviewed by the European Commission (EC).
Vizimprowas approved by the U.S. Food and Drug
Administration (FDA) in 2018 for the first-line treatment of patients
with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R
substitution mutations as detected by an FDA-approved test. It was also
recently approved in Japan for EGFR gene mutation-positive, inoperable
or recurrent NSCLC.
“Patients with EGFR-mutated non-small cell lung cancer, a disease that
is associated with low overall survival rates, are in need of more
treatment options. This positive CHMP opinion is an important step
toward bringing this treatment to patients in Europe as a potential new
first-line treatment option,” said Chris Boshoff, M.D., Ph.D., Chief
Development Officer, Oncology, Pfizer Global Product Development.
“Vizimpro’s development is a direct result of Pfizer’s focus on
precision drug development to create tailored options that improve
patient outcomes.”
The Marketing Authorization Application (MAA) for Vizimpro was based on
results from ARCHER 1050, a randomized, multicenter, multinational,
open-label, Phase 3 study conducted in patients with locally advanced
unresectable, or metastatic NSCLC harboring EGFR exon 19 deletion or
exon 21 L858R substitution mutations, an Eastern Cooperative Oncology
Group (ECOG) performance status of 0 or 1; with no prior therapy for
metastatic disease or recurrent disease with a minimum of 12 months
disease-free after completion of systemic therapy. A total of 452
patients were randomized 1:1 to Vizimpro 45 mg (n=227) or gefitinib 250
mg (n=225).
About Vizimpro® (dacomitinib)
Vizimpro is an oral, once-daily, irreversible pan-human epidermal growth
factor receptor kinase inhibitor for first-line treatment of adult
patients with locally advanced or metastatic non-small cell lung cancer
(NSCLC) with epidermal growth factor receptor (EGFR)-activating
mutations.
Vizimpro is approved in the U.S. for the first-line treatment of
patients with metastatic non-small cell lung cancer (NSCLC) with
epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21
L858R substitution mutations as detected by an FDA-approved test.
Vizimpro is also approved in Japan for EGFR gene mutation-positive,
inoperable or recurrent NSCLC. The applications in the US and Japan were
reviewed and approved under the Priority Review program.
In 2012, Pfizer and SFJ Pharmaceuticals entered into a collaborative
development agreement to conduct ARCHER 1050 across multiple sites. SFJ
is a global drug development company, which provides a unique and highly
customized co-development partnering model for the world’s top
pharmaceutical and biotechnology companies. Under the terms of this
agreement, SFJ Pharmaceuticals provided the funding and conducted the
trial to generate the clinical data used to support this application.
Pfizer retains all rights to commercialize Vizimpro globally.
About ARCHER 1050
The efficacy of Vizimpro was demonstrated in ARCHER 1050, a global Phase
3 head-to-head trial conducted in patients with locally advanced
unresectable, or metastatic non-small cell lung cancer (NSCLC) harboring
epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21
L858R substitution mutations, with no prior therapy for metastatic
disease or recurrent disease with a minimum of 12 months disease-free
after completion of systemic therapy. A total of 452 patients were
randomized 1:1 to Vizimpro 45 mg (n=227) or gefitinib 250 mg (n=225).
Randomization was stratified by region and EGFR mutation status. The
primary endpoint of the study was progression-free survival (PFS) as
determined by blinded Independent Radiology Central (IRC) review. Key
secondary endpoints included objective response rate (ORR), duration of
response (DoR), overall survival (OS), and patient-reported outcomes
(PROs).
VIZIMPRO® (dacomitinib) IMPORTANT SAFETY INFORMATION FROM THE U.S.
PRESCRIBING INFORMATION
There are no contraindications for VIZIMPRO.
Interstitial Lung Disease (ILD): Severe and fatal ILD/pneumonitis
occurred in patients treated with VIZIMPRO and occurred in 0.5% of the
394 VIZIMPRO-treated patients; 0.3% of cases were fatal. Monitor
patients for pulmonary symptoms indicative of ILD/pneumonitis. Withhold
VIZIMPRO and promptly investigate for ILD in patients who present with
worsening of respiratory symptoms which may be indicative of ILD (e.g.,
dyspnea, cough, and fever). Permanently discontinue VIZIMPRO if ILD is
confirmed.
Diarrhea: Severe and fatal diarrhea occurred in patients treated
with VIZIMPRO. Diarrhea occurred in 86% of the 394 VIZIMPRO-treated
patients. Grade 3 or 4 diarrhea was reported in 11% of patients and 0.3%
of cases were fatal. Withhold VIZIMPRO for Grade 2 or greater diarrhea
until recovery to less than or equal to Grade 1 severity, then resume
VIZIMPRO at the same or a reduced dose depending on the severity of
diarrhea. Promptly initiate anti-diarrheal treatment (loperamide or
diphenoxylate hydrochloride with atropine sulfate) for diarrhea.
Dermatologic Adverse Reactions: Rash and exfoliative skin
reactions occurred in patients treated with VIZIMPRO. Rash occurred in
78% of the 394 VIZIMPRO-treated patients. Grade 3 or 4 rash was reported
in 21% of patients. Exfoliative skin reactions of any severity were
reported in 7% of patients. Grade 3 or 4 exfoliative skin reactions were
reported in 1.8% of patients. Withhold VIZIMPRO for persistent Grade 2
or any Grade 3 or 4 dermatologic adverse reaction until recovery to less
than or equal to Grade 1 severity, then resume VIZIMPRO at the same or a
reduced dose depending on the severity of the dermatologic adverse
reaction. The incidence and severity of rash and exfoliative skin
reactions may increase with sun exposure. At the time of initiation of
VIZIMPRO, initiate use of moisturizers and appropriate measures to limit
sun exposure. Upon development of Grade 1 rash, initiate treatment with
topical antibiotics and topical steroids. Initiate oral antibiotics for
Grade 2 or more severe dermatologic adverse reactions.
Embryo-Fetal Toxicity: VIZIMPRO can cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the potential
risk to the fetus. Advise females of reproductive potential to use
effective contraception during treatment with VIZIMPRO and for at least
17 days after the final dose.
Adverse Reactions: The most common (>20%) adverse reactions were
diarrhea (87%), rash (69%), paronychia (64%), stomatitis (45%),
decreased appetite (31%), dry skin (30%), decreased weight (26%),
alopecia (23%), cough (21%), and pruritus (21%). The most common (≥1%)
serious adverse reactions were diarrhea (2.2%) and interstitial lung
disease (1.3%).
Drug Interactions: Concomitant use with a proton pump inhibitor
(PPI) decreases dacomitinib concentrations, which may reduce VIZIMPRO
efficacy. Avoid the concomitant use of PPIs with VIZIMPRO. As an
alternative to PPIs, use locally-acting antacids or an H2-receptor
antagonist. Administer VIZIMPRO at least 6 hours before or 10 hours
after taking an H2-receptor antagonist. Concomitant use of VIZIMPRO
increases the concentration of drugs that are CYP2D6 substrates which
may increase the risk of toxicities of these drugs. Avoid concomitant
use of VIZIMPRO with CYP2D6 substrates where minimal increases in
concentration of the CYP2D6 substrate may lead to serious or
life-threatening toxicities.
Lactation: Because of the potential for serious adverse reactions
in breastfed infants from VIZIMPRO, advise women not to breastfeed
during treatment with VIZIMPRO and for at least 17 days after the last
dose.
Hepatic Impairment: No dose adjustment is recommended in patients
with mild or moderate hepatic impairment. The recommended dose of
VIZIMPRO has not been established for patients with severe hepatic
impairment.
Renal Impairment: No dose adjustment is recommended for patients
with mild or moderate renal impairment. The recommended dose of VIZIMPRO
has not been established for patients with severe renal impairment.
Please see full prescribing information at www.VIZIMPRO.com.
About Non-Small Cell Lung Cancer
Lung cancer is the most common cancer worldwide, with more than two
million new cases diagnosed globally in 2018.1 About 85
percent of all lung cancers are identified as non-small cell, and
approximately 75 percent of these are metastatic, or advanced, at
diagnosis.2
EGFR is a protein that helps cells grow and divide. When the EGFR gene
is mutated it can cause the protein to be overactive resulting in cancer
cells to form. EGFR mutations may occur in 10 to 35 percent of NSCLC
tumors globally, and most common activating mutations are deletions in
exon 19 and exon 21 L858R substitution, which together account for more
than 80 percent of known activating EGFR mutations. The disease is
associated with low survival rates and disease progression remains a
challenge.1,2
About Pfizer in Lung Cancer
Pfizer Oncology is committed to addressing the unmet needs of patients
with lung cancer, the leading cause of cancer-related deaths worldwide
and a particularly difficult-to-treat disease. Pfizer strives to address
the diverse and evolving needs of patients with non-small cell lung
cancer (NSCLC) by developing efficacious and tolerable therapies,
including biomarker-driven therapies and immuno-oncology (IO) agents and
combinations. By combining leading scientific insights with a
patient-centric approach, Pfizer is continually advancing its work to
match the right patient with the right medicine at the right time.
Through our growing research pipeline and collaboration efforts, we are
committed to delivering renewed hope to patients living with NSCLC.
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines wherever we
believe we can make a meaningful difference on the lives of patients.
Today, Pfizer Oncology has an industry-leading portfolio of 17 approved
innovative cancer medicines and biosimilars across more than 20
indications, including breast, prostate, kidney, lung and hematology. We
also have several assets in mid to late-stage development for the
treatment of cancer or as supportive care. Pfizer Oncology is striving
to change the trajectory of cancer.
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,
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DISCLOSURE NOTICE:
The information contained in this release is as of February 1, 2019.
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 Pfizer’s
oncology portfolio, VIZIMPRO (dacomitinib), a kinase inhibitor,
including a potential indication in the EU and their potential benefits
that involve 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, 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 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 applications for VIZIMPRO
may be filed in other jurisdictions; whether and when the European
Commission may approve the pending application for VIZIMPRO in the EU
and whether and when any such other applications for VIZIMPRO that may
be pending or filed 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; uncertainties regarding the
commercial success of VIZIMPRO; decisions by regulatory authorities
impacting labeling, manufacturing processes and/or other matters that
could affect the availability or commercial potential of VIZIMPRO; 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, 2017 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
.
1 Lovly CM, Horn L. Molecular profiling of lung cancer. My
Cancer Genome; 2016. https://www.mycancergenome.org/content/disease/lung-cancer/.
Accessed January 2019.
2 Pao W, Miller VA. Epidermal
growth factor receptor mutations, small-molecule kinase inhibitors, and
non-small-cell lung cancer: current knowledge and future directions. J
Clin Oncol. 2005;23:2556-2568.
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Pfizer Media Contacts:
Jessica Smith (U.S.)
(212) 733-6213
Jessica.M.Smith@pfizer.com
Lisa
O’Neill (EU)
(44) 7929 339 560
Lisa.O'Neill@pfizer.com
Pfizer
Investor Contact:
Ryan Crowe
(212) 733-8160
Ryan.Crowe@pfizer.com
Source: Pfizer Inc.