LORBRENA Addresses Unmet Needs for Certain
Patients Treated With Prior ALK Therapy
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and
Drug Administration (FDA) has approved LORBRENA® [lor-BREN-ah]
(lorlatinib), a third-generation anaplastic lymphoma kinase (ALK)
tyrosine kinase inhibitor (TKI) for patients with ALK-positive
metastatic non-small cell lung cancer (NSCLC) whose disease has
progressed on crizotinib and at least one other ALK inhibitor for
metastatic disease; or whose disease has progressed on alectinib or
ceritinib as the first ALK inhibitor therapy for metastatic
disease. This indication is approved under accelerated approval
based on tumor response rate and duration of response. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in a confirmatory trial. This
represents the third FDA approval Pfizer has received for an
oncology treatment, including two lung cancer medicines, within two
months.
“Over the years, Pfizer has transformed research, management and
treatment for patients with ALK-positive non-small cell lung
cancer. Building upon our extensive understanding of tumor
complexity and treatment resistance, LORBRENA was discovered by
Pfizer scientists and developed specifically to inhibit tumor
mutations that may drive resistance to other ALK tyrosine kinase
inhibitors,” said Andy Schmeltz, Global President, Pfizer Oncology.
“We believe that LORBRENA will benefit patients with ALK-positive
metastatic non-small cell lung cancer that have progressed on prior
therapy and continue to deliver on our commitment to addressing
unmet needs of cancer patients.”
Since Pfizer introduced XALKORI® (crizotinib) as the first TKI
for the treatment of ALK-positive metastatic NSCLC in 2011, the
availability of these medicines has created an opportunity to
provide patients with treatment options other than chemotherapy.
However, lung cancer remains the leading cause of cancer-related
death around the world.
While many ALK-positive metastatic NSCLC patients respond to
initial TKI therapy, they typically experience tumor
progression.1,2 Additionally, options for patients who progress
after treatment with second-generation ALK TKIs, alectinib,
brigatinib and ceritinib, are limited.3 The approval of LORBRENA
represents a new option for patients who have progressed on a
second-generation ALK TKI, providing an opportunity to remain on
oral therapy.
“The last decade has witnessed dramatic improvements in the
treatment of metastatic ALK-positive non-small cell lung cancer due
to earlier generation ALK biomarker-driven therapies. Yet almost
all patients still relapse due to drug resistance, with a large
proportion of patients developing new or worsening brain
metastases,” said Alice T. Shaw, MD, PhD, Professor of Medicine at
Harvard Medical School, and Director of the Center for Thoracic
Cancers at Massachusetts General Hospital. “In a clinical study
which included patients with or without brain metastases, LORBRENA
demonstrated clinical activity in patients with metastatic
ALK-positive non-small cell lung cancer who had failed other ALK
biomarker-driven therapies.”
The approval was based on a non-randomized, dose-ranging and
activity-estimating, multi-cohort, multicenter Phase 1/2 study,
B7461001, evaluating LORBRENA for the treatment of patients with
ALK-positive metastatic NSCLC, who were previously treated with one
or more ALK TKIs. A total of 215 patients with ALK-positive
metastatic NSCLC were enrolled across various subgroups based on
prior treatment. Among these patients, overall response rate (ORR)
was 48 percent (95% CI: 42%, 55%) and importantly, 57 percent had
previous treatment with more than one ALK TKI. In the trial, 69
percent of patients had a history of brain metastases and
intracranial response rate was 60 percent (95% CI: 49%, 70%).
“Since leading with the first approval of a biomarker-driven
treatment for ALK-positive non-small cell lung cancer in 2011,
Pfizer scientists and clinicians have remained committed to
researching and developing medicines that can further advance the
care of these patients,” said Mace Rothenberg, MD, Chief
Development Officer, Oncology, Pfizer Global Product Development.
“LORBRENA’s approval is an important milestone for patients, having
demonstrated marked activity in a study that included a broad range
of individuals with ALK-positive non-small cell lung cancer. This
includes patients who were heavily pretreated and facing limited
options after receiving first- and second-generation ALK tyrosine
kinase inhibitors.”
Among 295 ALK-positive or ROS1-positive metastatic NSCLC
patients who received LORBRENA 100 mg once daily in study B7461001,
the most common (≥ 20%) adverse reactions were edema, peripheral
neuropathy, cognitive effects, dyspnea, fatigue, weight gain,
arthralgia, mood effects, and diarrhea. The most common (≥20%)
laboratory abnormalities were hypercholesterolemia,
hypertriglyceridemia, anemia, hyperglycemia, increased AST,
hypoalbuminemia, increased ALT, increased lipase, and increased
alkaline phosphatase. Serious adverse reactions occurred in 32
percent of the 295 patients. The most frequent serious adverse
reactions reported were pneumonia (3.4%), dyspnea (2.7%), pyrexia
(2%), mental status changes (1.4%), and respiratory failure (1.4%).
Fatal adverse reactions occurred in 2.7 percent of patients and
included pneumonia (0.7%), myocardial infarction (0.7%), acute
pulmonary edema (0.3%), embolism (0.3%), peripheral artery
occlusion (0.3%), and respiratory distress (0.3%). Permanent
discontinuation of LORBRENA for adverse reactions occurred in eight
percent of patients; approximately 48 percent of patients required
dose interruptions and 24 percent required at least one dose
reduction. The full prescribing information for LORBRENA can be
found here.
Pfizer is committed to ensuring that patients living with lung
cancer have access to this innovative therapy. Patients in the U.S.
who are prescribed LORBRENA have access to Pfizer Oncology
TogetherTM, which offers personalized patient support including
financial assistance and additional resources to help them manage
day-to-day life with their condition.
About LORBRENA® (lorlatinib)
LORBRENA is indicated for the treatment of patients with
anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell
lung cancer (NSCLC) whose disease has progressed on crizotinib and
at least one other ALK inhibitor for metastatic disease; or whose
disease has progressed on alectinib or ceritinib as the first ALK
inhibitor therapy for metastatic disease.
This indication is approved under accelerated approval based on
tumor response rate and duration of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in a confirmatory trial.
LORBRENA is currently approved in Japan for the treatment of ALK
fusion gene-positive unresectable advanced and/or recurrent
non-small cell lung cancer with resistance or intolerance to ALK
tyrosine kinase inhibitor(s).
IMPORTANT LORBRENA SAFETY INFORMATION FROM THE U.S.
PRESCRIBING INFORMATION
Contraindications: LORBRENA is contraindicated in
patients taking strong CYP3A inducers, due to the potential for
serious hepatotoxicity.
Risk of Serious Hepatotoxicity with Concomitant Use of Strong
CYP3A Inducers: Severe hepatotoxicity occurred in 10 of 12
healthy subjects receiving a single dose of LORBRENA with multiple
daily doses of rifampin, a strong CYP3A inducer. Grade 4 ALT or AST
elevations occurred in 50% of subjects, Grade 3 in 33% of subjects,
and Grade 2 in 8% of subjects. Discontinue strong CYP3A inducers
for 3 plasma half-lives of the strong CYP3A inducer prior to
initiating LORBRENA. Avoid concomitant use of LORBRENA with
moderate CYP3A inducers. If concomitant use of moderate CYP3A
inducers cannot be avoided, monitor AST, ALT, and bilirubin 48
hours after initiating LORBRENA and at least 3 times during the
first week after initiating LORBRENA. Depending upon the relative
importance of each drug, discontinue LORBRENA or the CYP3A inducer
for persistent Grade 2 or higher hepatotoxicity.
Central Nervous System (CNS) Effects: A broad spectrum of
CNS effects can occur. These include seizures, hallucinations, and
changes in cognitive function, mood (including suicidal ideation),
speech, mental status, and sleep. Withhold and resume at the same
or reduced dose or permanently discontinue based on severity.
Hyperlipidemia: Increases in serum cholesterol and
triglycerides can occur. Grade 3 or 4 elevations in total
cholesterol occurred in 17% and Grade 3 or 4 elevations in
triglycerides occurred in 17% of the 332 patients who received
LORBRENA. Eighty percent of patients required initiation of
lipid-lowering medications, with a median time to onset of start of
such medications of 21 days. Initiate or increase the dose of
lipid-lowering agents in patients with hyperlipidemia. Monitor
serum cholesterol and triglycerides before initiating LORBRENA, 1
and 2 months after initiating LORBRENA, and periodically
thereafter. Withhold and resume at same dose for the first
occurrence; resume at same or reduced dose of LORBRENA for
recurrence based on severity.
Atrioventricular (AV) Block: PR interval prolongation and
AV block can occur. In 295 patients who received LORBRENA at a dose
of 100 mg orally once daily and who had a baseline
electrocardiography (ECG), 1% experienced AV block and 0.3%
experienced Grade 3 AV block and underwent pacemaker placement.
Monitor ECG prior to initiating LORBRENA and periodically
thereafter. Withhold and resume at reduced or same dose in patients
who undergo pacemaker placement. Permanently discontinue for
recurrence in patients without a pacemaker.
Interstitial Lung Disease (ILD)/Pneumonitis: Severe or
life-threatening pulmonary adverse reactions consistent with
ILD/pneumonitis can occur. ILD/pneumonitis occurred in 1.5% of
patients, including Grade 3 or 4 ILD/pneumonitis in 1.2% of
patients. Promptly investigate for ILD/pneumonitis in any patient
who presents with worsening of respiratory symptoms indicative of
ILD/pneumonitis. Immediately withhold LORBRENA in patients with
suspected ILD/pneumonitis. Permanently discontinue LORBRENA for
treatment-related ILD/pneumonitis of any severity.
Embryo-fetal Toxicity: LORBRENA can cause fetal harm.
Advise pregnant women of the potential risk to a fetus. Advise
females of reproductive potential to use an effective non-hormonal
method of contraception, since LORBRENA can render hormonal
contraceptives ineffective, during treatment with LORBRENA and for
at least 6 months after the final dose. Advise males with female
partners of reproductive potential to use effective contraception
during treatment with LORBRENA and for 3 months after the final
dose.
Adverse Reactions: Serious adverse reactions occurred in
32% of the 295 patients; the most frequently reported serious
adverse reactions were pneumonia (3.4%), dyspnea (2.7%), pyrexia
(2%), mental status changes (1.4%), and respiratory failure (1.4%).
Fatal adverse reactions occurred in 2.7% of patients and included
pneumonia (0.7%), myocardial infarction (0.7%), acute pulmonary
edema (0.3%), embolism (0.3%), peripheral artery occlusion (0.3%),
and respiratory distress (0.3%). The most common (≥20%) adverse
reactions were edema, peripheral neuropathy, cognitive effects,
dyspnea, fatigue, weight gain, arthralgia, mood effects, and
diarrhea; the most common (≥20%) laboratory abnormalities were
hypercholesterolemia, hypertriglyceridemia, anemia, hyperglycemia,
increased AST, hypoalbuminemia, increased ALT, increased lipase,
and increased alkaline phosphatase.
Drug Interactions: LORBRENA is contraindicated in
patients taking strong CYP3A inducers. Avoid concomitant use with
moderate CYP3A inducers and strong CYP3A inhibitors. If concomitant
use of moderate CYP3A inducers cannot be avoided, monitor ALT, AST,
and bilirubin as recommended. If concomitant use with a strong
CYP3A inhibitor cannot be avoided, reduce the LORBRENA dose as
recommended. Concomitant use of LORBRENA decreases the
concentration of CYP3A substrates.
Lactation: Because of the potential for serious adverse
reactions in breastfed infants, instruct women not to breastfeed
during treatment with LORBRENA and for 7 days after the final
dose.
Hepatic Impairment: No dose adjustment is recommended for
patients with mild hepatic impairment. The recommended dose of
LORBRENA has not been established for patients with moderate or
severe hepatic impairment.
Renal Impairment: No dose adjustment is recommended for
patients with mild or moderate renal impairment. The recommended
dose of LORBRENA has not been established for patients with severe
renal impairment.
About Non-Small Cell Lung Cancer
Lung cancer is the leading cause of cancer death worldwide.4
NSCLC accounts for about 85 percent of lung cancer cases and
remains difficult to treat, particularly in the metastatic
setting.5 Approximately 75 percent of NSCLC patients are diagnosed
late with metastatic or advanced disease where the five-year
survival rate is only five percent.2,6,7
ALK gene rearrangement is a genetic alteration that drives the
development of lung cancer in some patients.8,9 Epidemiology
studies suggest that approximately three to five percent of NSCLC
tumors are ALK-positive.10,11
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 XALKORI® (crizotinib)
XALKORI is a tyrosine kinase inhibitor (TKI) indicated for the
treatment of patients with metastatic non-small cell lung cancer
(NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or
ROS1-positive as detected by an FDA-approved test. XALKORI has
received approval for patients with ALK-positive NSCLC in more than
90 countries including Australia, Canada, China, Japan, South
Korea and the European Union. XALKORI is also approved for
ROS1-positive NSCLC in more than 60 countries.
XALKORI® Important Safety Information
Hepatotoxicity: Drug-induced hepatotoxicity with fatal
outcome occurred in 0.1% of patients treated with XALKORI across
clinical trials (n=1719). Transaminase elevations generally
occurred within the first 2 months. Monitor liver function tests,
including ALT, AST, and total bilirubin, every 2 weeks during the
first 2 months of treatment, then once a month, and as clinically
indicated, with more frequent repeat testing for increased liver
transaminases, alkaline phosphatase, or total bilirubin in patients
who develop transaminase elevations. Permanently discontinue for
ALT/AST elevation >3 times ULN with concurrent total bilirubin
elevation >1.5 times ULN (in the absence of cholestasis or
hemolysis); otherwise, temporarily suspend and dose-reduce XALKORI
as indicated.
Interstitial Lung Disease (Pneumonitis): Severe,
life-threatening, or fatal interstitial lung disease
(ILD)/pneumonitis can occur. Across clinical trials (n=1719), 2.9%
of XALKORI-treated patients had any grade ILD, 1.0% had Grade 3/4,
and 0.5% had fatal ILD. ILD generally occurred within 3 months
after initiation of treatment. Monitor for pulmonary symptoms
indicative of ILD/pneumonitis. Exclude other potential causes and
permanently discontinue XALKORI in patients with drug-related
ILD/pneumonitis.
QT Interval Prolongation: QTc prolongation can occur.
Across clinical trials (n=1616), 2.1% of patients had QTcF
(corrected QT by the Fridericia method) ≥500 ms and 5.0% had an
increase from baseline QTcF ≥60 ms by automated machine-read
evaluation of ECGs. Avoid use in patients with congenital long QT
syndrome. Monitor ECGs and electrolytes in patients with congestive
heart failure, bradyarrhythmias, electrolyte abnormalities, or who
are taking medications that prolong the QT interval. Permanently
discontinue XALKORI in patients who develop QTc >500 ms or ≥60
ms change from baseline with Torsade de pointes, polymorphic
ventricular tachycardia, or signs/symptoms of serious arrhythmia.
Withhold XALKORI in patients who develop QTc >500 ms on at least
2 separate ECGs until recovery to a QTc ≤480 ms, then resume at a
reduced dose.
Bradycardia: Symptomatic bradycardia can occur. Across
clinical trials, bradycardia occurred in 12.7% of patients treated
with XALKORI (n=1719). Avoid use in combination with other agents
known to cause bradycardia. Monitor heart rate and blood pressure
regularly. In cases of symptomatic bradycardia that is not
life-threatening, hold XALKORI until recovery to asymptomatic
bradycardia or to a heart rate of ≥60 bpm, re-evaluate the use of
concomitant medications, and adjust the dose of XALKORI.
Permanently discontinue for life-threatening bradycardia due to
XALKORI; however, if associated with concomitant medications known
to cause bradycardia or hypotension, hold XALKORI until recovery to
asymptomatic bradycardia or to a heart rate of ≥60 bpm. If
concomitant medications can be adjusted or discontinued, restart
XALKORI at 250 mg once daily with frequent monitoring.
Severe Visual Loss: Across clinical trials, the incidence
of Grade 4 visual field defect with vision loss was 0.2% (n=1719).
Discontinue XALKORI in patients with new onset of severe visual
loss (best corrected vision less than 20/200 in one or both eyes).
Perform an ophthalmological evaluation. There is insufficient
information to characterize the risks of resumption of XALKORI in
patients with a severe visual loss; a decision to resume should
consider the potential benefits to the patient.
Vision Disorders: Most commonly visual impairment,
photopsia, blurred vision or vitreous floaters, occurred in 63.1%
of 1719 patients. The majority (95%) of these patients had Grade 1
visual adverse reactions. 0.8% of patients had Grade 3 and 0.2% had
Grade 4 visual impairment. The majority of patients on the XALKORI
arms in Studies 1 and 2 (>50%) reported visual disturbances
which occurred at a frequency of 4-7 days each week, lasted up to 1
minute, and had mild or no impact on daily activities.
Embryo-Fetal Toxicity: XALKORI can cause fetal harm when
administered to a pregnant woman. Advise of the potential risk to
the fetus. Advise females of reproductive potential and males with
female partners of reproductive potential to use effective
contraception during treatment and for at least 45 days (females)
or 90 days (males) respectively, following the final dose of
XALKORI.
ROS1-positive Metastatic NSCLC: Safety was evaluated in
50 patients with ROS1-positive metastatic NSCLC from a single-arm
study, and was generally consistent with the safety profile of
XALKORI evaluated in patients with ALK-positive metastatic NSCLC.
Vision disorders occurred in 92% of patients in the ROS1 study; 90%
of patients had Grade 1 vision disorders and 2% had Grade 2.
Adverse Reactions: Safety was evaluated in a phase 3
study in previously untreated patients with ALK-positive metastatic
NSCLC randomized to XALKORI (n=171) or chemotherapy (n=169).
Serious adverse events were reported in 34% of patients treated
with XALKORI, the most frequent were dyspnea (4.1%) and pulmonary
embolism (2.9%). Fatal adverse events in XALKORI-treated patients
occurred in 2.3% of patients, consisting of septic shock, acute
respiratory failure, and diabetic ketoacidosis. Common adverse
reactions (all grades) occurring in ≥25% and more commonly (≥5%) in
patients treated with XALKORI vs chemotherapy were vision disorder
(71% vs 10%), diarrhea (61% vs 13%), edema (49% vs 12%), vomiting
(46% vs 36%), constipation (43% vs 30%), upper respiratory
infection (32% vs 12%), dysgeusia (26% vs 5%), and abdominal pain
(26% vs 12%). Grade 3/4 reactions occurring at a ≥2% higher
incidence with XALKORI vs chemotherapy were QT prolongation (2% vs
0%), esophagitis (2% vs 0%), and constipation (2% vs 0%). In
patients treated with XALKORI vs chemotherapy, the following
occurred: elevation of ALT (any grade [79% vs 33%] or Grade 3/4
[15% vs 2%]); elevation of AST (any grade [66% vs 28%] or Grade 3/4
[8% vs 1%]); neutropenia (any grade [52% vs 59%] or Grade 3/4 [11%
vs 16%]); lymphopenia (any grade [48% vs 53%] or Grade 3/4 [7% vs
13%]); hypophosphatemia (any grade [32% vs 21%] or Grade 3/4 [10%
vs 6%]). In patients treated with XALKORI vs chemotherapy, renal
cysts occurred (5% vs 1%). Nausea (56%), decreased appetite (30%),
fatigue (29%), and neuropathy (21%) also occurred in patients
taking XALKORI.
Drug Interactions: Exercise caution with concomitant use
of moderate CYP3A inhibitors. Avoid grapefruit or grapefruit juice
which may increase plasma concentrations of crizotinib. Avoid
concomitant use of strong CYP3A inducers and inhibitors. Avoid
concomitant use of CYP3A substrates with narrow therapeutic range
in patients taking XALKORI. If concomitant use of CYP3A substrates
with narrow therapeutic range is required in patients taking
XALKORI, dose reductions of the CYP3A substrates may be required
due to adverse reactions.
Lactation: Because of the potential for adverse reactions
in breastfed infants, advise females not to breastfeed during
treatment with XALKORI and for 45 days after the final dose.
Hepatic Impairment: Crizotinib concentrations increased
in patients with pre-existing moderate (any AST and total bilirubin
>1.5x ULN and ≤3x ULN) or severe (any AST and total bilirubin
>3x ULN) hepatic impairment. Reduce XALKORI dose in patients
with moderate or severe hepatic impairment. The recommended dose of
XALKORI in patients with pre-existing moderate hepatic impairment
is 200 mg orally twice daily or with pre-existing severe hepatic
impairment is 250 mg orally once daily.
Renal Impairment: Decreases in estimated glomerular
filtration rate occurred in patients treated with XALKORI.
Administer XALKORI at a starting dose of 250 mg taken orally once
daily in patients with severe renal impairment (CLcr <30 mL/min)
not requiring dialysis.
For more information and full prescribing information, please
visit www.XALKORI.com.
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 13 approved cancer medicines across 21 indications,
including breast, prostate, kidney, lung and hematology. We also
have one of the deepest oncology biosimilars pipelines, with two
medicines approved globally and 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, 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
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care providers, governments and local communities to support and
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For more than 150 years, we have worked to make a difference for
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DISCLOSURE NOTICE: The information contained in this release is
as of November 2, 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 LORBRENA
(lorlatinib), including its 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 LORBRENA; the
uncertainties inherent in research and development, including 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 and when applications for LORBRENA may be
filed in any other jurisdictions; whether and when any such
applications for LORBRENA that maybe be pending or filed 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 LORBRENA will be
commercially successful; decisions by regulatory authorities
regarding labeling and other matters that could affect the
availability or commercial potential of LORBRENA; 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 Lin JJ, Riely GJ & Shaw AT, Targeting ALK: Precision
Medicine Takes on Drug Resistance, Cancer Discovery Volume 7, Issue
2, pp. 137-155, 2017
2 Shaw AT, et al. Alectinib versus crizotinib in treatment-naïve
advanced ALK-positive non-small cell lung cancer (NSCLC): Primary
results of the global phase III ALEX study. Presented at: ASCO
Annual Meeting; 2017 Jun 2-6; Chicago, IL, USA. Abstract
#LBA9008.
3 Mano H. Second-Generation ALK Inhibitors, Clinical Advances in
Hematology & Oncology Volume 13, Issue 7 July 2015.
4 World Health Organization. International Agency for Research
on Cancer. GLOBOCAN 2018: Lung fact sheet.
http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed September 2018.
5 Reade CA, Ganti AK. EGFR targeted therapy in non-small cell
lung cancer: potential role of cetuximab. Biologics. 2009; 3:
215–224.
6 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
7 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.
8 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.
9 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:
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