KEYTRUDA is Currently Approved in 39
Countries, including the United States and throughout the European
Union
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced the National Institute for Health and Care
Excellence (NICE) of the United Kingdom (U.K.) has issued a draft
recommendation, in the form of a Final Appraisal Determination
(FAD), recommending KEYTRUDA® (pembrolizumab) as a first-line
treatment option for adults with advanced melanoma.
“We are pleased that the U.K. government has recognized the
value of KEYTRUDA, and thank the government for its efforts to
ensure that patients in the U.K. who have advanced melanoma have
access to KEYTRUDA as soon as possible,” said Deepak Khanna, senior
vice president and regional president, Europe, MSD Oncology. “Merck
has demonstrated our strong commitment to ensuring KEYTRUDA would
be available as quickly as possible to patients in the U.K., and
around the world. Since the first approval in the United States
just more than a year ago, KEYTRUDA has been approved in 39
countries, including throughout the European Union.”
In addition to today’s NICE recommendation for KEYTRUDA as a
first-line treatment option for adults with advanced melanoma,
earlier this week NICE issued final guidance recommending KEYTRUDA
for the treatment of advanced melanoma after disease progression
with ipilimumab. KEYTRUDA was the first medicine available through
the U.K. Early Access to Medicines Scheme (EAMS), which was
introduced in the U.K. in 2014 to help patients with
life-threatening or seriously debilitating conditions benefit from
promising, innovative treatments before a European license has been
granted.
“The availability of KEYTRUDA for first-line use in patients
will be welcomed by the melanoma community,” said Gillian Nuttall,
Founder of Melanoma UK. “Advanced melanoma is a very difficult
disease to treat effectively and this treatment will give hope to
many. We are delighted that patients will be able to access this
treatment on the National Health Services and congratulate NICE on
their swift decision making.”
Securing approvals for KEYTRUDA globally is a key element of
Merck’s efforts to ensure that the medicine is broadly available
for eligible patients with advanced melanoma who are in need of new
options around the world. To date, KEYTRUDA has been approved for
the treatment of certain patients with advanced melanoma by
regulatory authorities in the United States and the EU, as well as
Australia, Canada, Israel, Macau, New Zealand, Peru, South Korea,
Switzerland, and the United Arab Emirates (UAE). Additionally, the
U.S. Food and Drug Administration (FDA) recently approved KEYTRUDA
for certain patients with advanced non-small cell lung cancer
(link).
About KEYTRUDA® (pembrolizumab) Injection 100
mg
KEYTRUDA is a humanized monoclonal antibody that works by
increasing the ability of the body’s immune system to help detect
and fight tumor cells. KEYTRUDA blocks the interaction between PD-1
and its ligands, PD-L1 and PD-L2, and may affect both tumor cells
and healthy cells.
KEYTRUDA is indicated in the U.S. at a dose of 2 mg/kg
administered as an intravenous infusion over 30 minutes every three
weeks for the treatment of patients with unresectable or metastatic
melanoma and disease progression following ipilimumab and, if BRAF
V600 mutation positive, a BRAF inhibitor. KEYTRUDA is also
indicated for the treatment of metastatic non-small cell lung
cancer (NSCLC) whose tumors express PD-L1 as determined by an
FDA-approved test with disease progression on or after
platinum-containing chemotherapy. Patients with EGFR or ALK genomic
tumor aberrations should have disease progression on FDA-approved
therapy for these aberrations prior to receiving KEYTRUDA. In the
U.S., these indications are approved under accelerated approval
based on tumor response rate and durability of response; an
improvement in survival or disease-related symptoms has not yet
been established. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
the confirmatory trials.
Selected Safety Information for KEYTRUDA in Advanced Melanoma
Trial
Pneumonitis occurred in 12 (2.9%) of 411 patients, including
Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively,
receiving KEYTRUDA. Monitor patients for signs and symptoms of
pneumonitis. Evaluate suspected pneumonitis with radiographic
imaging. Administer corticosteroids for Grade 2 or greater
pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue
KEYTRUDA for Grade 3 or 4 pneumonitis.
Colitis (including microscopic colitis) occurred in 4 (1%) of
411 patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%)
patients, respectively, receiving KEYTRUDA. Monitor patients for
signs and symptoms of colitis. Administer corticosteroids for Grade
2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3;
permanently discontinue KEYTRUDA for Grade 4 colitis.
Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%)
of 411 patients, including a Grade 4 case in 1 (0.2%) patient,
receiving KEYTRUDA. Monitor patients for changes in liver function.
Administer corticosteroids for Grade 2 or greater hepatitis and,
based on severity of liver enzyme elevations, withhold or
discontinue KEYTRUDA.
Hypophysitis occurred in 2 (0.5%) of 411 patients, including a
Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient,
receiving KEYTRUDA. Monitor patients for signs and symptoms of
hypophysitis (including hypopituitarism and adrenal insufficiency).
Administer corticosteroids for Grade 2 or greater hypophysitis.
Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3;
and permanently discontinue KEYTRUDA for Grade 4 hypophysitis.
Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including
Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients, respectively,
receiving KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411
patients, including a Grade 3 case in 1 (0.2%) patient, receiving
KEYTRUDA. Thyroid disorders can occur at any time during treatment.
Monitor patients for changes in thyroid function (at the start of
treatment, periodically during treatment, and as indicated based on
clinical evaluation) and for clinical signs and symptoms of thyroid
disorders. Administer corticosteroids for Grade 3 or greater
hyperthyroidism. Withhold KEYTRUDA for Grade 3; permanently
discontinue KEYTRUDA for Grade 4 hyperthyroidism. Isolated
hypothyroidism may be managed with replacement therapy without
treatment interruption and without corticosteroids.
Type 1 diabetes mellitus, including diabetic ketoacidosis, has
occurred in patients receiving KEYTRUDA. Monitor patients for
hyperglycemia and other signs and symptoms of diabetes. Administer
insulin for type 1 diabetes, and withhold KEYTRUDA in cases of
severe hyperglycemia until metabolic control is achieved.
Nephritis occurred in 3 (0.7%) patients, consisting of one case
of Grade 2 autoimmune nephritis (0.2%) and two cases of
interstitial nephritis with renal failure (0.5%), one Grade 3 and
one Grade 4. Monitor patients for changes in renal function.
Administer corticosteroids for Grade 2 or greater nephritis.
Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for
Grade 3 or 4 nephritis.
Other clinically important immune-mediated adverse reactions can
occur. The following clinically significant immune-mediated adverse
reactions occurred in patients treated with KEYTRUDA: exfoliative
dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic
anemia, partial seizures arising in a patient with inflammatory
foci in brain parenchyma, severe dermatitis including bullous
pemphigoid, myasthenic syndrome, optic neuritis, and
rhabdomyolysis.
For suspected immune-mediated adverse reactions, ensure adequate
evaluation to confirm etiology or exclude other causes. Based on
the severity of the adverse reaction, withhold KEYTRUDA and
administer corticosteroids. Upon improvement of the adverse
reaction to Grade 1 or less, initiate corticosteroid taper and
continue to taper over at least 1 month. Restart KEYTRUDA if the
adverse reaction remains at Grade 1 or less. Permanently
discontinue KEYTRUDA for any severe or Grade 3 immune-mediated
adverse reaction that recurs and for any life-threatening
immune-mediated adverse reaction.
Infusion-related reactions, including severe and
life-threatening reactions, have occurred in patients receiving
KEYTRUDA. Monitor patients for signs and symptoms of
infusion-related reactions including rigors, chills, wheezing,
pruritus, flushing, rash, hypotension, hypoxemia, and fever. For
severe or life-threatening reactions, stop infusion and permanently
discontinue KEYTRUDA.
Based on its mechanism of action, KEYTRUDA may cause fetal harm
when administered to a pregnant woman. If used during pregnancy, or
if the patient becomes pregnant during treatment, apprise the
patient of the potential hazard to a fetus. Advise females of
reproductive potential to use highly effective contraception during
treatment and for 4 months after the last dose of KEYTRUDA.
KEYTRUDA was discontinued for adverse reactions in 9% of 411
patients. Adverse reactions, reported in at least two patients,
that led to discontinuation of KEYTRUDA were: pneumonitis, renal
failure, and pain. Serious adverse reactions occurred in 36% of
patients. The most frequent serious adverse reactions, reported in
2% or more of patients, were renal failure, dyspnea, pneumonia, and
cellulitis.
The most common adverse reactions (reported in at least 20% of
patients) were fatigue (47%), cough (30%), nausea (30%), pruritus
(30%), rash (29%), decreased appetite (26%), constipation (21%),
arthralgia (20%), and diarrhea (20%).
The recommended dose of KEYTRUDA is 2 mg/kg administered as an
intravenous infusion over 30 minutes every three weeks until
disease progression or unacceptable toxicity. No formal
pharmacokinetic drug interaction studies have been conducted with
KEYTRUDA. It is not known whether KEYTRUDA is excreted in human
milk. Because many drugs are excreted in human milk, instruct women
to discontinue nursing during treatment with KEYTRUDA. Safety and
effectiveness of KEYTRUDA have not been established in pediatric
patients.
Selected Safety Information for KEYTRUDA in Metastatic NSCLC
Trial
Pneumonitis occurred in 19 (3.5%) of 550 patients, including
Grade 2 (1.1%), 3 (1.3%), 4 (0.4%), or 5 (0.2%) pneumonitis in
patients receiving KEYTRUDA. Monitor patients for signs and
symptoms of pneumonitis. Evaluate suspected pneumonitis with
radiographic imaging. Administer corticosteroids for Grade 2 or
greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently
discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2
pneumonitis.
Colitis occurred in 4 (0.7 %) of 550 patients, including Grade 2
(0.2%) or 3 (0.4%) colitis in patients receiving KEYTRUDA. Monitor
patients for signs and symptoms of colitis. Administer
corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA
for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4
colitis.
Hepatitis occurred in patients receiving KEYTRUDA. Monitor
patients for changes in liver function. Administer corticosteroids
for Grade 2 or greater hepatitis and, based on severity of liver
enzyme elevations, withhold or discontinue KEYTRUDA.
Hypophysitis occurred in 1 (0.2 %) of 550 patients, which was
Grade 3 in severity. Monitor patients for signs and symptoms of
hypophysitis (including hypopituitarism and adrenal insufficiency).
Administer corticosteroids and hormone replacement as indicated.
Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade
3 or Grade 4 hypophysitis.
Hyperthyroidism occurred in 10 (1.8%) of 550 patients, including
Grade 2 (0.7%) or 3 (0.3%). Hypothyroidism occurred in 38 (6.9%) of
550 patients, including Grade 2 (5.5%) or 3 (0.2%). Thyroid
disorders can occur at any time during treatment. Monitor patients
for changes in thyroid function (at the start of treatment,
periodically during treatment, and as indicated based on clinical
evaluation) and for clinical signs and symptoms of thyroid
disorders. Administer replacement hormones for hypothyroidism and
manage hyperthyroidism with thionamides and beta-blockers as
appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or Grade
4 hyperthyroidism.
Type 1 diabetes mellitus, including diabetic ketoacidosis, has
occurred in patients receiving KEYTRUDA. Monitor patients for
hyperglycemia or other signs and symptoms of diabetes. Administer
insulin for type 1 diabetes, and withhold KEYTRUDA and administer
anti-hyperglycemics in patients with severe hyperglycemia.
Nephritis occurred in patients receiving KEYTRUDA. Monitor
patients for changes in renal function. Administer corticosteroids
for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2;
permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.
For suspected immune-mediated adverse reactions, ensure adequate
evaluation to confirm etiology or exclude other causes. Based on
the severity of the adverse reaction, withhold KEYTRUDA and
administer corticosteroids. Upon improvement of the adverse
reaction to Grade 1 or less, initiate corticosteroid taper and
continue to taper over at least 1 month. Resume KEYTRUDA when the
adverse reaction remains at Grade 1 or less following steroid
taper. Permanently discontinue KEYTRUDA for any severe or Grade 3
immune-mediated adverse reaction that recurs and for any
life-threatening immune-mediated adverse reaction.
The following clinically significant, immune-mediated adverse
reactions occurred in patients treated with KEYTRUDA: rash,
vasculitis, hemolytic anemia, serum sickness, myasthenia gravis,
bullous pemphigoid, and Guillain-Barré syndrome.
Infusion-related reactions, including severe and
life-threatening reactions, have occurred in patients receiving
KEYTRUDA. Monitor patients for signs and symptoms of
infusion-related reactions including rigors, chills, wheezing,
pruritus, flushing, rash, hypotension, hypoxemia, and fever. For
severe or life-threatening reactions, stop infusion and permanently
discontinue KEYTRUDA.
Based on its mechanism of action, KEYTRUDA can cause fetal harm
when administered to a pregnant woman. If used during pregnancy, or
if the patient becomes pregnant during treatment, apprise the
patient of the potential hazard to a fetus. Advise females of
reproductive potential to use highly effective contraception during
treatment and for 4 months after the last dose of KEYTRUDA.
KEYTRUDA was discontinued due to adverse reactions in 14% of
patients. Serious adverse reactions occurred in 38% of patients.
The most frequent serious adverse reactions reported in 2% or more
of patients were pleural effusion, pneumonia, dyspnea, pulmonary
embolism, and pneumonitis.
The most common adverse reactions (reported in at least 20% of
patients) were fatigue (44%), decreased appetite (25%), dyspnea
(23%), and cough (29%).
Our Focus on Cancer
Our goal is to translate breakthrough science into innovative
oncology medicines to help people with cancer worldwide. At Merck
Oncology, helping people fight cancer is our passion and supporting
accessibility to our cancer medicines is our commitment. Our
focus is on pursuing research in immuno-oncology and we are
accelerating every step in the journey – from lab to clinic – to
potentially bring new hope to people with cancer. For more
information about our oncology clinical trials, visit
www.merck.com/clinicaltrials.
About Merck
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world be well. Merck is known as MSD outside the United States and
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therapies and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access
to healthcare through far-reaching policies, programs and
partnerships. For more information, visit www.merck.com and connect
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###
Please see Prescribing Information for KEYTRUDA
(pembrolizumab) at
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
and the Medication Guide for KEYTRUDA at
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf
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