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FDA Approves Lorbrena (lorlatinib) for Previously-Treated ALK-Positive Metastatic Non-Small Cell Lung Cancer

FDA Approves Lorbrena (lorlatinib) for Previously-Treated ALK-Positive Metastatic Non-Small Cell Lung Cancer

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FDA Approves Lorbrena (lorlatinib) for Previously-Treated ALK-Positive Metastatic Non-Small Cell Lung Cancer

November 2, 2018 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.

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

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 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 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
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:
10.1016

11 Garber K. ALK, lung cancer, and personalized therapy:
portent of the future? J Natl Cancer Inst. 2010;102:672-675.

Source: Pfizer Inc.

Posted: November 2018

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