– ALUNBRIG Demonstrated Unprecedented Median Progression-Free
Survival of 16.7 Months and Overall Survival of 34.1 Months in the
Post-Crizotinib Setting –
– Approval Will Help Address Current
Unmet Need in ALK+ NSCLC Treatment in the EU, Building Upon Approvals in
the U.S. and Canada – CAMBRIDGE, Mass. & OSAKA, Japan-Thursday 29 November 2018 [ AETOS Wire ]
(BUSINESS
WIRE) -- Takeda Pharmaceutical Company Limited (TSE: 4502) today
announced that the European Commission (EC) granted marketing
authorization for ALUNBRIG (brigatinib) as a monotherapy for the
treatment of adult patients with anaplastic lymphoma kinase-positive
(ALK+) advanced non-small cell lung cancer (NSCLC) previously treated
with crizotinib. The decision follows a positive opinion from the
Committee for Medicinal Products for Human Use (CHMP) on September 20,
2018.
“The introduction of targeted therapies has greatly
improved the treatment of ALK+ NSCLC, yet for the approximately 70
percent of patients who progress on crizotinib with brain metastases,
additional therapeutic options are needed,” said Enriqueta Felip, M.D.,
PhD., Head of the Thoracic Oncology Unit, Oncology Department at Vall
d’Hebron University Hospital in Barcelona. “Data from the ALTA trial
investigating ALUNBRIG showed sustained systemic and intracranial
efficacy results and a manageable safety profile, leading to the longest
progression-free survival and overall survival reported in this
setting. This approval gives physicians in the European Union another
choice in addressing ALK+ NSCLC patients previously treated with
crizotinib.”
“The European Commission’s decision to approve
ALUNBRIG for patients with ALK+ NSCLC is a significant advancement for
European patients impacted by this life-threatening disease,” said Jesús
Gómez-Navarro, M.D., Vice President, Head of Oncology Clinical Research
and Development, Takeda. “This is the first time a median
progression-free survival of over 16 months as assessed by an
independent review committee and median overall survival of 34 months
have been reported in the post-crizotinib setting, which highlights the
strength of the ALTA trial data. The authorization of ALUNBRIG in the EU
speaks to our ongoing commitment to developing innovative solutions to
improve the lives of the approximately 40,000 patients diagnosed with
this disease worldwide each year.”
“Many people are unaware of
ALK+ NSCLC and its nuances, including the fact this type of lung cancer
tends to affect people at a younger age, and it is not associated with
smoking,” said Stefania Vallone, President, Lung Cancer Europe. “These
younger patients are often in the prime of their lives and in the middle
of raising their families, focusing on their careers, and contributing
to their community. The availability of new treatments to potentially
extend time without disease progression is very important and cannot be
underestimated.”
The European Commission’s approval is based on
data from the global Phase 2 ALTA trial, in which patients were
randomized to receive one of two dosing regimens of ALUNBRIG: 90 mg once
daily (n=112) or the recommended dosing regimen of 180 mg once daily
with seven-day lead-in at 90 mg once daily (n=110). Results showed that
of the patients who received the recommended dosing regimen, 56 percent
achieved an objective response rate (ORR), and the median duration of
response (DOR) was 15.7 months as assessed by independent review
committee (IRC). ALUNBRIG demonstrated a median progression-free
survival (PFS) of 16.7 months by IRC assessment and overall survival of
34.1 months for patients with locally advanced or metastatic ALK+ NSCLC
who had progressed on crizotinib.
The most common adverse
reactions (≥25%) reported in patients treated with ALUNBRIG at the
recommended 180 mg dosing regimen were increased aspartate
aminotransferase (AST), hyperglycemia, hyperinsulinemia, anemia,
increased creatine phosphokinase (CPK), nausea, increased lipase,
decreased lymphocyte count, increased alanine aminotransferase (ALT),
diarrhea, increased amylase, fatigue, cough, headache, increased
alkaline phosphatase, hypophosphatemia, increased abnormal activated
partial thromboplastin time (APTT), rash, vomiting, dyspnea,
hypertension, decreased blood cell count, myalgia, and peripheral
neuropathy. The most common serious adverse reactions (≥ 2 percent)
reported in patients treated with ALUNBRIG at the recommended dosing
regimen other than events related to neoplasm progression were
pneumonitis, pneumonia, and dyspnea.
This decision by the
European Commission means that ALUNBRIG is now approved for marketing of
this indication in the 28 member states of the European Union, and
applicable in Norway, Liechtenstein and Iceland. For further details
about the European Commission decision, please visit the European
Medicines Agency website: www.ema.europe.eu/ema.
About the ALTA TrialThe Phase 2 ALTA (
ALK in
Lung Cancer
Trial of
AP26113)
trial of ALUNBRIG in adults is a global, ongoing, two-arm, open-label,
multicenter trial, which enrolled 222 patients with locally advanced or
metastatic ALK+ NSCLC who had progressed on crizotinib. Patients
received either 90 mg of ALUNBRIG once daily (n=112) or 180 mg once
daily with seven-day lead-in at 90 mg once daily regimen (n=110).
Investigator-assessed confirmed objective response rate (ORR) per RECIST
v1.1 was the primary endpoint. Key additional endpoints included
Independent Review Committee (IRC)-assessed ORR, duration of response
(DOR), progression-free survival (PFS), intracranial ORR, intracranial
DOR, safety and tolerability.
Results of the ALTA trial
demonstrated that of the patients who received the 180 mg dosing
regimen, 56 percent achieved an ORR as assessed by investigator and 56
percent as assessed by IRC. The median DOR was 13.8 months as assessed
by investigator and 15.7 months by IRC assessment. Median PFS was 15.6
months as assessed by investigator and 16.7 months by IRC assessment.
Additionally, of the patients with measurable brain metastases at
baseline (n=18), 67 percent achieved an intracranial ORR by IRC
assessment; median duration of intracranial response was 16.6 months by
IRC assessment. Median overall survival was 34.1 months.
Among
patients who received the 90 mg dosing regimen, 46 percent achieved an
ORR as assessed by investigator and 51 percent as assessed by IRC. The
median DOR was 12.0 months as assessed by investigator and 16.4 months
by IRC assessment. Median PFS was 9.2 months as assessed by both
investigator and IRC assessment. Additionally, of the patients with
measurable brain metastases at baseline (n=26), 50 percent achieved an
intracranial ORR by IRC assessment; median duration of intracranial
response was 9.4 months by IRC assessment. Median overall survival was
29.5 months.
About ALK+ NSCLCNon-small cell lung
cancer (NSCLC) is the most common form of lung cancer, accounting for
approximately 85 percent of the estimated 1.8 million new cases of lung
cancer diagnosed each year worldwide, according to the World Health
Organization. Genetic studies indicate that chromosomal rearrangements
in anaplastic lymphoma kinase (ALK) are key drivers in a subset of NSCLC
patients. Approximately three to five percent of patients with
metastatic NSCLC have a rearrangement in the ALK gene.
Takeda is
committed to continuing research and development in NSCLC to improve the
lives of the approximately 40,000 patients diagnosed with this serious
and rare form of lung cancer worldwide each year.
About ALUNBRIG® (brigatinib)ALUNBRIG
is a targeted cancer medicine discovered by ARIAD Pharmaceuticals,
Inc., which was acquired by Takeda in February 2017. In April 2017,
ALUNBRIG received Accelerated Approval from the U.S. Food and Drug
Administration (FDA) for ALK+ metastatic NSCLC patients who have
progressed on or are intolerant to crizotinib. 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. In July 2018, Health Canada approved ALUNBRIG for
the treatment of adult patients with ALK+ metastatic NSCLC who have
progressed on or who were intolerant to an ALK inhibitor (crizotinib).
The FDA and Health Canada approvals of ALUNBRIG were primarily based on
results from the pivotal Phase 2 ALTA (ALK in Lung Cancer Trial of
AP26113) trial.
ALUNBRIG received Breakthrough Therapy
Designation from the FDA for the treatment of patients with ALK+ NSCLC
whose tumors are resistant to crizotinib and was granted Orphan Drug
Designation by the FDA for the treatment of ALK+ NSCLC, ROS1+ and EGFR+
NSCLC.
The brigatinib clinical development program further
reinforces Takeda’s ongoing commitment to developing innovative
therapies for people living with ALK+ NSCLC worldwide and the healthcare
professionals who treat them. The comprehensive program includes the
following clinical trials:
- Phase
1/2 trial, which was designed to evaluate the safety, tolerability,
pharmacokinetics and preliminary anti-tumor activity of ALUNBRIG
- Pivotal
Phase 2 ALTA trial investigating the efficacy and safety of ALUNBRIG at
two dosing regimens in patients with ALK+ locally advanced or
metastatic NSCLC who had progressed on crizotinib
- Phase 3
ALTA-1L, a global randomized trial assessing the efficacy and safety of
ALUNBRIG in comparison to crizotinib in patients with ALK+ locally
advanced or metastatic NSCLC who have not received prior treatment with
an ALK inhibitor
- Phase 2 single-arm, multicenter trial in
Japanese patients with ALK+ NSCLC, focusing on patients who have
progressed on alectinib
- Phase 2 global, single arm trial
evaluating ALUNBRIG in patients with advanced ALK+ NSCLC who have
progressed on alectinib or ceritinib
- Phase 3 global randomized
trial comparing the efficacy and safety of ALUNBRIG versus alectinib in
participants with ALK+ NSCLC who have progressed on crizotinib
For additional information on the brigatinib clinical trials, please visit www.clinicaltrials.gov.
ALUNBRIG® (brigatinib): EUROPEAN IMPORTANT SAFETY INFORMATION
SPECIAL WARNINGS AND PRECAUTIONS FOR USEPulmonary Adverse Reactions:
Severe, life-threatening, and fatal pulmonary adverse reactions,
including those with features consistent with ILD/pneumonitis, can
occur. Most pulmonary adverse reactions were observed within the first 7
days of treatment. Grade 1-2 pulmonary adverse reactions resolved with
interruption of treatment or dose modification. Increased age and
shorter interval (less than 7 days) between the last dose of crizotinib
and the first dose of ALUNBRIG were independently associated with an
increased rate of these pulmonary adverse reactions. Consider these
factors when initiating treatment with ALUNBRIG. Some patients
experienced pneumonitis later in treatment with ALUNBRIG. Patients
should be monitored for new or worsening respiratory symptoms (e.g.,
dyspnoea, cough, etc.), particularly in the first week of treatment.
Evidence of pneumonitis in any patient with worsening respiratory
symptoms should be promptly investigated. If pneumonitis is suspected,
the dose of ALUNBRIG should be withheld, and the patient evaluated for
other causes of symptoms (e.g., pulmonary embolism, tumour progression,
and infectious pneumonia). The dose should be modified accordingly.
Hypertension has
occurred. Blood pressure should be monitored regularly during treatment
with ALUNBRIG. Hypertension should be treated according to standard
guidelines to control blood pressure. Heart rate should be monitored
more frequently in patients if concomitant use of a medication known to
cause bradycardia cannot be avoided. For severe hypertension (≥ Grade
3), ALUNBRIG should be withheld until hypertension has recovered to
Grade 1 or to baseline. The dose should be modified accordingly.
Bradycardia has
occurred. Caution should be exercised when administering ALUNBRIG in
combination with other agents known to cause bradycardia. Heart rate and
blood pressure should be monitored regularly. Treatment with ALUNBRIG
should be withheld if symptomatic bradycardia occurs. Concomitant
medications known to cause bradycardia should be evaluated. Upon
recovery, dose should be modified accordingly. In case of
life-threatening bradycardia, permanently discontinue ALUNBRIG if no
contributing concomitant medication is identified or in the case of
recurrence. If contributing concomitant medication is identified, modify
dose accordingly.
Visual Disturbance has occurred
with ALUNBRIG. Patients should be advised to report any visual symptoms.
For new or worsening severe visual symptoms, an ophthalmologic
evaluation and dose reduction should be considered.
Creatine Phosphokinase (CPK) Elevation
has been reported. Advise patients to report any unexplained muscle
pain, tenderness, or weakness. Monitor CPK levels regularly during
treatment. Based on the severity of the CPK elevation, withhold
treatment with ALUNBRIG and modify dose accordingly.
Pancreatic Enzyme Elevation:
Elevations of amylase and lipase have occurred. Lipase and amylase
should be monitored regularly during treatment with ALUNBRIG. Based on
the severity of the laboratory abnormalities, withhold ALUNBRIG and
modify dose accordingly.
Hepatotoxicity: Elevations
of hepatic enzymes (aspartate aminotransferase, alanine
aminotransferase) and bilirubin have occurred. Liver function, including
AST, ALT and total bilirubin should be assessed prior to the initiation
of ALUNBRIG and then every 2 weeks during the first 3 months of
treatment. Thereafter, monitoring should be performed periodically.
Based on the severity of the laboratory abnormalities, withhold ALUNBRIG
and modify dose accordingly.
Hyperglycemia:
Elevations of serum glucose have occurred. Fasting serum glucose should
be assessed prior to initiation of ALUNBRIG and monitored periodically
thereafter. Antihyperglycaemic treatment should be initiated or
optimised as needed. If adequate hyperglycaemic control cannot be
achieved with optimal medical management, ALUNBRIG should be withheld
until adequate hyperglycaemic control is achieved; upon recovery
reducing the dose may be considered or ALUNBRIG may be permanently
discontinued.
Drug drug interactions: Concomitant
use of ALUNBRIG with strong CYP3A inhibitors should be avoided. If
concomitant use of strong CYP3A inhibitors cannot be avoided, reduce
dose of ALUNBRIG from 180 mg to 90 mg, or from 90 mg to 60 mg. After
discontinuation of a strong CYP3A inhibitor, ALUNBRIG should be resumed
at the dose that was tolerated prior to the initiation of the strong
CYP3A inhibitor. The concomitant use of ALUNBRIG with strong and
moderate CYP3A inducers should be avoided.
Fertility:
Women of childbearing potential should be advised to use effective
non-hormonal contraception during treatment with ALUNBRIG and for at
least 4 months following the final dose. Men with female partners of
childbearing potential should be advised to use effective contraception
during treatment and for at least 3 months after the last dose of
ALUNBRIG
Lactose: ALUNBRIG contains lactose
monohydrate. Patients with rare hereditary problems of galactose
intolerance, total lactase deficiency or glucose-galactose malabsorption
should not take this medication.
UNDESIRABLE EFFECTSThe
most common adverse reactions (≥ 25%) reported in patients treated with
ALUNBRIG at the recommended dosing regimen were increased AST,
hyperglycaemia, hyperinsulinaemia, anaemia, increased CPK, nausea,
increased lipase, decreased lymphocyte count, increased ALT, diarrhoea,
increased amylase, fatigue, cough, headache, increased alkaline
phosphatase, hypophosphataemia, increased APTT, rash, vomiting,
dyspnoea, hypertension, decreased white blood cell count, myalgia, and
peripheral neuropathy.
The most common serious adverse reactions
(≥ 2%) reported in patients treated with ALUNBRIG at the recommended
dosing regimen other than events related to neoplasm progression were
pneumonitis, pneumonia, and dyspnoea.
SPECIAL POPULATIONSElderly patients:
The limited data on the safety and efficacy of ALUNBRIG in patients
aged 65 years and older suggest that a dose adjustment is not required
in elderly patients. There are no available data on patients over 85
years of age.
Hepatic impairment: No dose adjustment of
ALUNBRIG is required for patients with mild hepatic impairment
(Child-Pugh class A) or moderate hepatic impairment (Child-Pugh class
B). A reduced starting dose of 60 mg once daily for the first 7 days,
then 120 mg once daily is recommended for patients with severe hepatic
impairment (Child-Pugh class C).
Renal impairment: No dose
adjustment of ALUNBRIG is required for patients with mild or moderate
renal impairment (estimated glomerular filtration rate (eGFR) ≥ 30
mL/min). A reduced starting dose of 60 mg once daily for the first 7
days, then 90 mg once daily is recommended for patients with severe
renal impairment (eGFR < 30 mL/min). Patients with severe renal
impairment should be closely monitored for new or worsening respiratory
symptoms that may indicate ILD/pneumonitis (e.g., dyspnoea, cough, etc.)
particularly in the first week.
Paediatric population: The safety and efficacy of ALUNBRIG in patients less than 18 years of age have not been established. No data are available.
IMPORTANT SAFETY INFORMATION (U.S.)
WARNINGS AND PRECAUTIONSInterstitial Lung Disease (ILD)/Pneumonitis:
Severe, life-threatening, and fatal pulmonary adverse reactions
consistent with interstitial lung disease (ILD)/pneumonitis have
occurred with ALUNBRIG. In Trial ALTA (ALTA), ILD/pneumonitis occurred
in 3.7% of patients in the 90 mg group (90 mg once daily) and 9.1% of
patients in the 90→180 mg group (180 mg once daily with 7-day lead-in at
90 mg once daily). Adverse reactions consistent with possible
ILD/pneumonitis occurred early (within 9 days of initiation of ALUNBRIG;
median onset was 2 days) in 6.4% of patients, with Grade 3 to 4
reactions occurring in 2.7%. Monitor for new or worsening respiratory
symptoms (e.g., dyspnea, cough, etc.), particularly during the first
week of initiating ALUNBRIG. Withhold ALUNBRIG in any patient with new
or worsening respiratory symptoms, and promptly evaluate for
ILD/pneumonitis or other causes of respiratory symptoms (e.g., pulmonary
embolism, tumor progression, and infectious pneumonia). For Grade 1 or 2
ILD/pneumonitis, either resume ALUNBRIG with dose reduction after
recovery to baseline or permanently discontinue ALUNBRIG. Permanently
discontinue ALUNBRIG for Grade 3 or 4 ILD/pneumonitis or recurrence of
Grade 1 or 2 ILD/pneumonitis.
Hypertension: In ALTA,
hypertension was reported in 11% of patients in the 90 mg group who
received ALUNBRIG and 21% of patients in the 90→180 mg group. Grade 3
hypertension occurred in 5.9% of patients overall. Control blood
pressure prior to treatment with ALUNBRIG. Monitor blood pressure after 2
weeks and at least monthly thereafter during treatment with ALUNBRIG.
Withhold ALUNBRIG for Grade 3 hypertension despite optimal
antihypertensive therapy. Upon resolution or improvement to Grade 1
severity, resume ALUNBRIG at a reduced dose. Consider permanent
discontinuation of treatment with ALUNBRIG for Grade 4 hypertension or
recurrence of Grade 3 hypertension. Use caution when administering
ALUNBRIG in combination with antihypertensive agents that cause
bradycardia.
Bradycardia: Bradycardia can occur with
ALUNBRIG. In ALTA, heart rates less than 50 beats per minute (bpm)
occurred in 5.7% of patients in the 90 mg group and 7.6% of patients in
the 90→180 mg group. Grade 2 bradycardia occurred in 1 (0.9%) patient in
the 90 mg group. Monitor heart rate and blood pressure during treatment
with ALUNBRIG. Monitor patients more frequently if concomitant use of
drug known to cause bradycardia cannot be avoided. For symptomatic
bradycardia, withhold ALUNBRIG and review concomitant medications for
those known to cause bradycardia. If a concomitant medication known to
cause bradycardia is identified and discontinued or dose adjusted,
resume ALUNBRIG at the same dose following resolution of symptomatic
bradycardia; otherwise, reduce the dose of ALUNBRIG following resolution
of symptomatic bradycardia. Discontinue ALUNBRIG for life-threatening
bradycardia if no contributing concomitant medication is identified.
Visual Disturbance:
In ALTA, adverse reactions leading to visual disturbance including
blurred vision, diplopia, and reduced visual acuity, were reported in
7.3% of patients treated with ALUNBRIG in the 90 mg group and 10% of
patients in the 90→180 mg group. Grade 3 macular edema and cataract
occurred in one patient each in the 90→180 mg group. Advise patients to
report any visual symptoms. Withhold ALUNBRIG and obtain an
ophthalmologic evaluation in patients with new or worsening visual
symptoms of Grade 2 or greater severity. Upon recovery of Grade 2 or
Grade 3 visual disturbances to Grade 1 severity or baseline, resume
ALUNBRIG at a reduced dose. Permanently discontinue treatment with
ALUNBRIG for Grade 4 visual disturbances.
Creatine Phosphokinase (CPK) Elevation:
In ALTA, creatine phosphokinase (CPK) elevation occurred in 27% of
patients receiving ALUNBRIG in the 90 mg group and 48% of patients in
the 90 mg→180 mg group. The incidence of Grade 3-4 CPK elevation was
2.8% in the 90 mg group and 12% in the 90→180 mg group. Dose reduction
for CPK elevation occurred in 1.8% of patients in the 90 mg group and
4.5% in the 90→180 mg group. Advise patients to report any unexplained
muscle pain, tenderness, or weakness. Monitor CPK levels during ALUNBRIG
treatment. Withhold ALUNBRIG for Grade 3 or 4 CPK elevation. Upon
resolution or recovery to Grade 1 or baseline, resume ALUNBRIG at the
same dose or at a reduced dose.
Pancreatic Enzyme Elevation:
In ALTA, amylase elevation occurred in 27% of patients in the 90 mg
group and 39% of patients in the 90→180 mg group. Lipase elevations
occurred in 21% of patients in the 90 mg group and 45% of patients in
the 90→180 mg group. Grade 3 or 4 amylase elevation occurred in 3.7% of
patients in the 90 mg group and 2.7% of patients in the 90→180 mg group.
Grade 3 or 4 lipase elevation occurred in 4.6% of patients in the 90 mg
group and 5.5% of patients in the 90→180 mg group. Monitor lipase and
amylase during treatment with ALUNBRIG. Withhold ALUNBRIG for Grade 3 or
4 pancreatic enzyme elevation. Upon resolution or recovery to Grade 1
or baseline, resume ALUNBRIG at the same dose or at a reduced dose.
Hyperglycemia:
In ALTA, 43% of patients who received ALUNBRIG experienced new or
worsening hyperglycemia. Grade 3 hyperglycemia, based on laboratory
assessment of serum fasting glucose levels, occurred in 3.7% of
patients. Two of 20 (10%) patients with diabetes or glucose intolerance
at baseline required initiation of insulin while receiving ALUNBRIG.
Assess fasting serum glucose prior to initiation of ALUNBRIG and monitor
periodically thereafter. Initiate or optimize anti-hyperglycemic
medications as needed. If adequate hyperglycemic control cannot be
achieved with optimal medical management, withhold ALUNBRIG until
adequate hyperglycemic control is achieved and consider reducing the
dose of ALUNBRIG or permanently discontinuing ALUNBRIG.
Embryo-Fetal Toxicity:
Based on its mechanism of action and findings in animals, ALUNBRIG can
cause fetal harm when administered to pregnant women. There are no
clinical data on the use of ALUNBRIG in pregnant women. Advise pregnant
women of the potential risk to a fetus. Advise females of reproductive
potential to use effective non-hormonal contraception during treatment
with ALUNBRIG and for at least 4 months following the final dose. Advise
males with female partners of reproductive potential to use effective
contraception during treatment and for at least 3 months after the last
dose of ALUNBRIG.
ADVERSE REACTIONSSerious adverse
reactions occurred in 38% of patients in the 90 mg group and 40% of
patients in the 90→180 mg group. The most common serious adverse
reactions were pneumonia (5.5% overall, 3.7% in the 90 mg group, and
7.3% in the 90→180 mg group) and ILD/pneumonitis (4.6% overall, 1.8% in
the 90 mg group and 7.3% in the 90→180 mg group). Fatal adverse
reactions occurred in 3.7% of patients and consisted of pneumonia (2
patients), sudden death, dyspnea, respiratory failure, pulmonary
embolism, bacterial meningitis and urosepsis (1 patient each).
The
most common adverse reactions (≥25%) in the 90 mg group were nausea
(33%), fatigue (29%), headache (28%), and dyspnea (27%) and in the
90→180 mg group were nausea (40%), diarrhea (38%), fatigue (36%), cough
(34%), and headache (27%).
DRUG INTERACTIONSCYP3A Inhibitors:
Avoid concomitant use of ALUNBRIG with strong CYP3A inhibitors. Avoid
grapefruit or grapefruit juice as it may also increase plasma
concentrations of brigatinib. If concomitant use of a strong CYP3A
inhibitor is unavoidable, reduce the dose of ALUNBRIG.
CYP3A Inducers: Avoid concomitant use of ALUNBRIG with strong CYP3A inducers.
CYP3A Substrates:
Coadministration of ALUNBRIG with CYP3A substrates, including hormonal
contraceptives, can result in decreased concentrations and loss of
efficacy of CYP3A substrates.
USE IN SPECIFIC POPULATIONSPregnancy: ALUNBRIG can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus.
Lactation:
There are no data regarding the secretion of brigatinib in human milk
or its effects on the breastfed infant or milk production. Because of
the potential adverse reactions in breastfed infants, advise lactating
women not to breastfeed during treatment with ALUNBRIG.
Females and Males of Reproductive Potential:Contraception:
Advise females of reproductive potential to use effective non-hormonal
contraception during treatment with ALUNBRIG and for at least 4 months
after the final dose. Advise males with female partners of reproductive
potential to use effective contraception during treatment with ALUNBRIG
and for at least 3 months after the final dose.
Infertility: ALUNBRIG may cause reduced fertility in males.
Pediatric Use: The safety and efficacy of ALUNBRIG in pediatric patients have not been established.
Geriatric Use:
Clinical studies of ALUNBRIG did not include sufficient numbers of
patients aged 65 years and older to determine whether they respond
differently from younger patients. Of the 222 patients in ALTA, 19.4%
were 65-74 years and 4.1% were 75 years or older. No clinically relevant
differences in safety or efficacy were observed between patients ≥65
and younger patients.
Hepatic or Renal Impairment: No dose
adjustment is recommended for patients with mild hepatic impairment or
mild or moderate renal impairment. The safety of ALUNBRIG in patients
with moderate or severe hepatic impairment or severe renal impairment
has not been studied.
Please see the full U.S. Prescribing Information for ALUNBRIG at www.ALUNBRIG.com
About Takeda Pharmaceutical CompanyTakeda
Pharmaceutical Company Limited is a global, research and
development-driven pharmaceutical company committed to bringing better
health and a brighter future to patients by translating science into
life-changing medicines. Takeda focuses its R&D efforts on oncology,
gastroenterology and central nervous system therapeutic areas plus
vaccines. Takeda conducts R&D both internally and with partners to
stay at the leading edge of innovation. New innovative products,
especially in oncology and gastroenterology, as well as our presence in
Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda
employees are committed to improving quality of life for patients,
working with our partners in health care in more than 70 countries. For
more information, visit http://www.takeda.com/news.
Additional
information about Takeda is available through its corporate website,
www.takeda.com, and additional information about Takeda Oncology, the
brand for the global oncology business unit of Takeda Pharmaceutical
Company Limited, is available through its website,
www.takedaoncology.com.
ContactsTakeda Pharmaceutical Company Limited
Japanese MediaKazumi Kobayashi
kazumi.kobayashi@takeda.com
+81 3 3 278 2095
Media outside JapanAmanda Loder
Amanda.Loder@takeda.com
+1-212-259-0491
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