U.S. New Drug Application Granted FDA Priority Review
NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug
Administration (FDA) accepted and granted Priority Review to the
company’s New Drug Application for lorlatinib. Lorlatinib is an
investigational, anaplastic lymphoma kinase (ALK) tyrosine kinase
inhibitor (TKI) for the treatment of patients with ALK-positive
metastatic non-small cell lung cancer (NSCLC), previously treated with
one or more ALK TKIs. The European Medicines Agency and the Japan
Pharmaceutical and Medical Devices Agency have also accepted marketing
applications for the use of lorlatinib.
“Treatment resistance resulting in disease progression is a major
challenge faced by patients with ALK-positive metastatic NSCLC.
Lorlatinib was developed by Pfizer scientists with the specific goal of
overcoming resistance to first- and second-generation ALK-targeted
therapies,” said Mace Rothenberg, MD, chief development officer,
Oncology, Pfizer Global Product Development. “The encouraging results
observed in a variety of patients previously treated with ALK inhibitors
provides the basis for these applications.”
The FDA grants Priority Review to medicines that may offer significant
advances in treatment or may provide a treatment where no adequate
therapy exists. In April 2017, lorlatinib received Breakthrough Therapy
Designation from the FDA for patients with ALK-positive metastatic NSCLC
previously treated with one or more ALK inhibitors.
The submissions are based on Phase 2 data from a Phase 1/2 clinical
trial (NCT01970865) of lorlatinib, evaluating patients treated in
distinct cohorts based on prior therapy. Full results from the Phase 2
portion of the trial were presented at the International Association for
the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer
(WCLC) in October 2017.1
The Prescription Drug User Fee Act (PDUFA) goal date for a decision by
the FDA is in August 2018.
About Non-Small Cell Lung Cancer
Lung cancer is the leading cause of cancer death worldwide.2
NSCLC accounts for about 85 percent of lung cancer cases and remains
difficult to treat, particularly in the metastatic setting.3
Approximately 75 percent of NSCLC patients are diagnosed late with
metastatic or advanced disease where the five-year survival rate is only
five percent.2,4,5
ALK gene rearrangement is a genetic alteration that drives the
development of lung cancer in some patients.6,7 Epidemiology
studies suggest that approximately three to five percent of NSCLC tumors
are ALK-positive.8
About Lorlatinib
Lorlatinib is an investigational TKI that has been shown to be highly
active in preclinical lung cancer models harboring chromosomal
rearrangements of both ALK and ROS1. Lorlatinib was specifically
designed to inhibit tumor mutations that drive resistance to other ALK
inhibitors and to penetrate the blood brain barrier.
The Phase 3 CROWN study (NCT03052608) of lorlatinib began enrolling
patients earlier this year. CROWN is an ongoing, open label, randomized,
two-arm study comparing lorlatinib to crizotinib for treatment-naïve
patients with metastatic ALK-positive NSCLC.
Lorlatinib is an investigational agent and has not received regulatory
approval anywhere in the world. A multi-center, open-label expanded
access protocol (NCT03178071) is now open in the United States for
lorlatinib, making it available for eligible adults with ALK-positive or
ROS1-positive advanced NSCLC at select sites. More information can be
found by visiting www.clinicaltrials.gov.
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 death worldwide
and a particularly difficult-to-treat disease. Pfizer strives to address
the diverse and evolving needs of patients with 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
Pfizer Oncology is committed to pursuing innovative treatments that have
a meaningful impact on people living with cancer. Our growing pipeline
of biologics, small molecules, and immunotherapies is focused on
identifying and translating the best scientific breakthroughs into
clinical application for patients across a diverse array of solid tumors
and hematologic cancers. Today, we have 10 approved oncology medicines
and 17 assets currently in clinical development. By maximizing our
internal scientific resources and collaborating with other companies,
government and academic institutions, as well as non-profit and
professional organizations, we are bringing together the brightest and
most enterprising minds to take on the toughest cancers. Together we can
accelerate breakthrough treatments to patients around the world and work
to redefine life with cancer.
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, 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 12, 2018. 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 a product
candidate, lorlatinib, and Pfizer Oncology, 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, the uncertainties inherent in research and development,
including, without limitation, 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; the risk that clinical trial data are subject to
differing interpretations, and, even when we view data as sufficient to
support the safety and/or effectiveness of a product candidate,
regulatory authorities may not share our views and may require
additional data or may deny approval altogether; whether regulatory
authorities will be satisfied with the design of and results from our
clinical studies; whether and when new drug applications may be filed in
any other jurisdictions for lorlatinib; whether and when the
applications for lorlatinib pending with the FDA, the European Medicines
Agency and the Japan Pharmaceutical and Medical Devices Agency or 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, and, if approved, whether lorlatinib will
be commercially successful; decisions by regulatory authorities
regarding labeling and other matters that could affect the availability
or commercial potential of lorlatinib; 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, 2016 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 Solomon B., et al. Phase 2 Study of Lorlatinib in Patients
with Advanced ALK+ /ROS1+ Non-Small-Cell Lung Cancer. As presented at
the International Association for the Study of Lung Cancer (IASLC) 18th
World Conference on Lung Cancer. October 16, 2017. Abstract #OA 05.06.
2 The International Agency for Research on Cancer, the World
Health Organization, GLOBOCAN 2008, Available at: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx
(select “Lung” from the drop-down menu). Accessed February 2018.
3 Reade CA, Ganti AK. EGFR targeted therapy in non-small cell
lung cancer: potential role of cetuximab. Biologics. 2009; 3: 215–224.
4 Yang P, Allen MS, Aubry MC, et al. Clinical features of
5,628 primary lung cancer patients: experience at Mayo Clinic from 1997
to 2003. Chest. 2005; 128 (1):452–462.
5 American Cancer Society. Detailed Guide: Lung Cancer
(Non-Small Cell). Available at: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-survival-rates.
Accessed February 2018.
6 Chiarle R, Voena C, Ambrogio C, et al. The anaplastic
lymphoma kinase in the pathogenesis of cancer. Nat Rev Cancer.
2008;8(1):11-23.
7 Guérin A, Sasane M, Zhang J et al. ALK rearrangement
testing and treatment patterns for patients with ALK-positive non-small
cell lung cancer. Cancer Epidemiol. 2015 Jun; 39(3): 307-12. doi:
10.1016.
8 Garber K. ALK, lung cancer, and personalized therapy:
portent of the future? J Natl Cancer Inst. 2010;102:672-675.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180212005207/en/
Source: Pfizer Inc.