FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer

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May 18, 2017 3:00 pm ET

Now Approved for First-Line Treatment in Patients Ineligible for Cisplatin-Containing Chemotherapy and Second-Line Treatment in Patients Who Have Disease Progression During or Following Platinum-Containing Chemotherapy or Within 12 Months of Neoadjuvant or Adjuvant Treatment with Platinum-Containing Chemotherapy

KEYTRUDA is the Only Anti-PD-1 Therapy to Demonstrate Superior Overall Survival Versus Chemotherapy in Patients With Advanced Urothelial Carcinoma Post-Platinum Failure

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the U.S. Food and Drug Administration (FDA) has
approved two new indications for KEYTRUDA® (pembrolizumab),
the company’s anti-PD-1 therapy, for certain patients with locally
advanced or metastatic urothelial carcinoma, a type of bladder cancer.
In the first-line setting, KEYTRUDA is now approved for the treatment of
patients with locally advanced or metastatic urothelial carcinoma who
are ineligible for cisplatin-containing chemotherapy. 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 the
confirmatory trials. In the second-line setting, KEYTRUDA is now
approved for the treatment of patients with locally advanced or
metastatic urothelial carcinoma who have disease progression during or
following platinum-containing chemotherapy or within 12 months of
neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
KEYTRUDA is approved for use in these indications at a fixed dose of 200
mg every three weeks until disease progression or unacceptable toxicity,
or up to 24 months in patients without disease progression.

Immune-mediated adverse reactions occurred with KEYTRUDA including
pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Based
on the severity of the adverse reaction, KEYTRUDA should be withheld or
discontinued and corticosteroids administered if appropriate. KEYTRUDA
can also cause severe or life-threatening infusion-related reactions.
Monitor patients for signs and symptoms of infusion-related reactions;
for Grade 3 or 4 reactions, stop infusion and permanently discontinue
KEYTRUDA (pembrolizumab). Based on its mechanism of action, KEYTRUDA can
cause fetal harm when administered to a pregnant woman. Female patients
of reproductive potential should be advised of the potential hazard to a
fetus. For more information regarding immune-mediated and
infusion-related adverse reactions and use in pregnancy, see “Selected
Important Safety Information” below.

“KEYTRUDA is now available for use as a first-line treatment option for
patients with advanced urothelial bladder cancer who are not eligible
for the standard of care, cisplatin-based chemotherapy,” said Dean F.
Bajorin, M.D., study investigator and medical oncologist at Memorial
Sloan Kettering Cancer Center. “With the second-line indication,
KEYTRUDA also provides a new option for patients with advanced
urothelial bladder cancer – and is the only anti-PD-1 therapy to show an
overall survival benefit versus chemotherapy in a phase 3 study.”

“These two indications mark important additions to the growing list of
tumors and treatment settings for which KEYTRUDA is now approved. This
FDA approval further demonstrates Merck’s commitment to help improve the
lives of patients with many types of advanced cancer,” said Dr. Roger M.
Perlmutter, president, Merck Research Laboratories.

The KEYTRUDA clinical development program includes more than 30 tumor
types in nearly 500 clinical trials, including more than 250 trials that
combine KEYTRUDA with other cancer treatments. Currently, Merck has the
largest immuno-oncology clinical development program in bladder cancer,
with 29 trials underway involving KEYTRUDA as monotherapy and in
combination, including four registration-enabling studies.

Data Supporting First-Line Cisplatin-Ineligible Approval

The first-line approval is based on data from a multicenter, open-label,
single-arm trial, KEYNOTE-052, investigating KEYTRUDA in 370 patients
with locally advanced or metastatic urothelial carcinoma who were not
eligible for cisplatin-containing chemotherapy. Patients with autoimmune
disease or medical conditions that required systemic corticosteroids or
other immunosuppressive medication were excluded from the trial.
Patients received KEYTRUDA at a dose of 200 mg every three weeks until
unacceptable toxicity or disease progression; patients without disease
progression could be treated for up to 24 months. The major efficacy
outcome measures were objective response rate (ORR), according to the
Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed
by independent radiology review, and duration of response.

The efficacy analysis showed an ORR of 29 percent (95% CI: 24, 34), with
a complete response rate of 7 percent and a partial response rate of 22
percent. The median duration of response had not been reached (range:
1.4+ to 17.8+ months). The median follow-up time was 7.8 months.

In KEYNOTE-052, KEYTRUDA (pembrolizumab) was discontinued due to adverse
reactions in 11 percent of patients. The most common adverse reactions
(in ≥ 20% of patients) were fatigue (38%), musculoskeletal pain (24%),
decreased appetite (22%), constipation (21%), rash (21%) and diarrhea
(20%). Eighteen patients (5%) died from causes other than disease
progression. Five patients (1.4%) who were treated with KEYTRUDA
experienced sepsis which led to death, and three patients (0.8%)
experienced pneumonia which led to death. Adverse reactions leading to
interruption of KEYTRUDA occurred in 22 percent of patients; the most
common (≥1%) were liver enzyme increase, diarrhea, urinary tract
infection, acute kidney injury, fatigue, joint pain, and pneumonia.
Serious adverse reactions occurred in 42 percent of patients, the most
frequent (≥2%) of which were urinary tract infection, hematuria, acute
kidney injury, pneumonia, and urosepsis.

Data Supporting Second-Line Post-Platinum Failure Approval

The second-line approval is based on data from a multicenter,
randomized, active-controlled trial, KEYNOTE-045, investigating KEYTRUDA
in patients with locally advanced or metastatic urothelial carcinoma
with disease progression on or after platinum-containing chemotherapy.
Patients with autoimmune disease or a medical condition that required
immunosuppression were excluded from the trial. Patients were randomized
to receive either KEYTRUDA 200 mg every three weeks (n=270) or
investigator’s choice of any of the following chemotherapy regimens, all
given intravenously, every three weeks (n=272): paclitaxel 175 mg/m2
(n=84), docetaxel 75 mg/m2 (n=84), or vinflunine 320 mg/m2
(n=87). Treatment continued until unacceptable toxicity or disease
progression; patients without disease progression could be treated for
up to 24 months. The major efficacy outcomes were overall survival (OS)
and progression-free survival (PFS), as assessed by a blinded
independent central review (BICR) per RECIST 1.1; additional efficacy
outcome measures were ORR, as assessed by BICR per RECIST 1.1, and
duration of response.

KEYTRUDA demonstrated superior OS compared to chemotherapy. Findings
demonstrated that KEYTRUDA resulted in a 27 percent reduction in the
risk of death compared to chemotherapy – with 155 events (57%) observed
in the KEYTRUDA arm, compared to 179 events (66%) in the chemotherapy
arm (HR, 0.73 [95% CI: 0.59, 0.91], p=0.004); the median OS was 10.3
months (95% CI: 8.0, 11.8) in the KEYTRUDA arm, compared to 7.4 months
(95% CI: 6.1, 8.3) in the chemotherapy arm. In October 2016, the study
was stopped early at the recommendation of an independent Data
Monitoring Committee following an interim analysis that showed KEYTRUDA
met the superiority thresholds for OS in the overall study population.

There was no statistically significant difference between KEYTRUDA
(pembrolizumab) and chemotherapy with respect to PFS. There were 218
events (81%) observed in the KEYTRUDA arm, compared to 219 events (81%)
in the chemotherapy arm (HR, 0.98 [95% CI: 0.81, 1.19], p=0.833). The
median PFS was 2.1 months (95% CI: 2.0, 2.2) in the KEYTRUDA arm,
compared to 3.3 months (95% CI: 2.3, 3.5) in the chemotherapy arm.

Analysis of the ORR endpoint showed a statistically significant
improvement with KEYTRUDA, as compared to chemotherapy. The ORR was 21
percent (95% CI: 16, 27) in the KEYTRUDA arm (with a complete response
rate of 7 percent and a partial response rate of 14 percent), compared
to 11 percent (95% CI: 8, 16) in the chemotherapy arm (with a complete
response rate of 3 percent and a partial response rate of 8 percent)
(p=0.002). The median duration of response for patients treated with
KEYTRUDA had not yet been reached (range: 1.6+ to 15.6+ months),
compared to 4.3 months (range: 1.4+ to 15.4+ months) in the chemotherapy
arm. The median follow-up time for this trial was 9.0 months.

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in
eight percent of patients. The most common adverse reaction resulting in
permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Adverse
reactions leading to interruption of KEYTRUDA occurred in 20 percent of
patients; the most common (≥1%) were urinary tract infection (1.5%),
diarrhea (1.5%), and colitis (1.1%). The most common adverse reactions
(≥20%) in patients who received KEYTRUDA versus those who received
chemotherapy were fatigue (38% vs 56%), musculoskeletal pain (32% vs
27%), pruritus (23% vs 6%), decreased appetite (21% vs 21%), nausea (21%
vs 29%) and rash (20% vs 13%). Serious adverse reactions occurred in 39
percent of KEYTRUDA-treated patients, the most frequent (≥2%) of which
were urinary tract infection, pneumonia, anemia, and pneumonitis.

About KEYTRUDA

®

(pembrolizumab) Injection

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of
the body’s immune system to help detect and fight tumor cells. KEYTRUDA
is a humanized monoclonal antibody that blocks the interaction between
PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes
which may affect both tumor cells and healthy cells.

Studies of KEYTRUDA – from the largest immuno-oncology program in the
industry with nearly 500 trials – include a wide variety of cancers and
treatment settings. The KEYTRUDA clinical program seeks to understand
factors that predict a patient’s likelihood of benefitting from
treatment with KEYTRUDA, including the exploration of several different
biomarkers across a broad range of tumors.

KEYTRUDA (pembrolizumab) is administered as an intravenous infusion over
30 minutes every three weeks for the approved indications. KEYTRUDA for
injection is supplied in a 100 mg single-dose vial.

KEYTRUDA (pembrolizumab) Indications and Dosing

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or
metastatic melanoma at a fixed dose of 200 mg every three weeks until
disease progression or unacceptable toxicity.

Lung Cancer

KEYTRUDA, as a single agent, is indicated for the first-line treatment
of patients with metastatic non-small cell lung cancer (NSCLC) whose
tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as
determined by an FDA-approved test, with no EGFR or ALK genomic tumor
aberrations.

KEYTRUDA, as a single agent, is also indicated for the treatment of
patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) 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.

KEYTRUDA, in combination with pemetrexed and carboplatin, is indicated
for the first-line treatment of patients with metastatic nonsquamous
NSCLC. This indication is approved under accelerated approval based on
tumor response rate and progression-free survival. Continued approval
for this indication may be contingent upon verification and description
of clinical benefit in the confirmatory trials.

In metastatic NSCLC, KEYTRUDA is administered at a fixed dose of 200 mg
every three weeks until disease progression, unacceptable toxicity, or
up to 24 months in patients without disease progression.

When administering KEYTRUDA in combination with chemotherapy, KEYTRUDA
should be administered prior to chemotherapy when given on the same day.
See also the Prescribing Information for pemetrexed and carboplatin.

Head and Neck Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or
metastatic head and neck squamous cell carcinoma (HNSCC) with disease
progression on or after platinum-containing chemotherapy. This
indication is approved under accelerated approval based on tumor
response rate and durability of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in the confirmatory trials. In HNSCC, KEYTRUDA
(pembrolizumab) is administered at a fixed dose of 200 mg every three
weeks until disease progression, unacceptable toxicity, or up to 24
months in patients without disease progression.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients
with refractory classical Hodgkin lymphoma (cHL), or who have relapsed
after three or more prior lines of therapy. This indication is approved
under accelerated approval based on tumor response rate and durability
of response. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in the
confirmatory trials. In adults with cHL, KEYTRUDA is administered at a
fixed dose of 200 mg every three weeks until disease progression or
unacceptable toxicity, or up to 24 months in patients without disease
progression. In pediatric patients with cHL, KEYTRUDA is administered at
a dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until
disease progression or unacceptable toxicity, or up to 24 months in
patients without disease progression.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally
advanced or metastatic urothelial carcinoma who are not eligible for
cisplatin-containing chemotherapy. 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 the confirmatory
trials.

KEYTRUDA is also indicated for the treatment of patients with locally
advanced or metastatic urothelial carcinoma who have disease progression
during or following platinum-containing chemotherapy or within 12 months
of neoadjuvant or adjuvant treatment with platinum-containing
chemotherapy.

In locally advanced or metastatic urothelial carcinoma, KEYTRUDA is
administered at a fixed dose of 200 mg every three weeks until disease
progression or unacceptable toxicity, or up to 24 months in patients
without disease progression.

Selected Important Safety Information for KEYTRUDA

®
 (pembrolizumab)

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases.
Pneumonitis occurred in 94 (3.4%) of 2799 patients receiving KEYTRUDA,
including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%)
pneumonitis, and occurred more frequently in patients with a history of
prior thoracic radiation (6.9%) compared to those without (2.9%).
Monitor patients for signs and symptoms of pneumonitis. Evaluate
suspected pneumonitis with radiographic imaging. Administer
corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA
(pembrolizumab) for Grade 2; permanently discontinue KEYTRUDA for Grade
3 or 4 or recurrent Grade 2 pneumonitis.

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 48
(1.7%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.4%), 3
(1.1%), and 4 (<0.1%) colitis. 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.

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 19
(0.7%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.1%), 3
(0.4%), and 4 (<0.1%) hepatitis. 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.

KEYTRUDA can cause hypophysitis. Hypophysitis occurred in 17 (0.6%) of
2799 patients receiving KEYTRUDA, including Grade 2 (0.2%), 3 (0.3%),
and 4 (<0.1%) hypophysitis. Monitor patients for signs and symptoms of
hypophysitis (including hypopituitarism and adrenal insufficiency).
Administer corticosteroids and hormone replacement as clinically
indicated. Withhold KEYTRUDA for Grade 2; withhold or discontinue for
Grade 3 or 4 hypophysitis.

KEYTRUDA can cause thyroid disorders, including hyperthyroidism,
hypothyroidism, and thyroiditis. Hyperthyroidism occurred in 96 (3.4%)
of 2799 patients receiving KEYTRUDA, including Grade 2 (0.8%) and 3
(0.1%) hyperthyroidism. Hypothyroidism occurred in 237 (8.5%) of 2799
patients receiving KEYTRUDA, including Grade 2 (6.2%) and 3 (0.1%)
hypothyroidism. Thyroiditis occurred in 16 (0.6%) of 2799 patients
receiving KEYTRUDA, including Grade 2 (0.3%) thyroiditis. 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 4 hyperthyroidism.

KEYTRUDA can cause type 1 diabetes mellitus, including diabetic
ketoacidosis, which have been reported in 6 (0.2%) of 2799 patients.
Monitor patients for hyperglycemia or other signs and symptoms of
diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA
and administer antihyperglycemics in patients with severe hyperglycemia.

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 9
(0.3%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.1%), 3
(0.1%), and 4 (<0.1%) nephritis. Monitor patients for changes in renal
function. Administer corticosteroids for Grade 2 or greater nephritis.
Withhold KEYTRUDA (pembrolizumab) for Grade 2; permanently discontinue
KEYTRUDA for Grade 3 or 4 nephritis.

KEYTRUDA can cause other clinically important immune-mediated adverse
reactions. 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 to Grade 1 or less,
initiate corticosteroid taper and continue to taper over at least 1
month. Based on limited data from clinical studies in patients whose
immune-related adverse reactions could not be controlled with
corticosteroid use, administration of other systemic immunosuppressants
can be considered. Resume KEYTRUDA when the adverse reaction remains at
Grade 1 or less following corticosteroid taper. Permanently discontinue
KEYTRUDA for any 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 less than 1% (unless otherwise indicated) of 2799 patients:
arthritis (1.5%), exfoliative dermatitis, bullous pemphigoid, rash
(1.4%), uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis,
vasculitis, pancreatitis, hemolytic anemia, and partial seizures arising
in a patient with inflammatory foci in brain parenchyma. In addition,
myelitis and myocarditis were reported in other clinical trials,
including cHL, and postmarketing use.

Solid organ transplant rejection has been reported in postmarketing use
of KEYTRUDA. Treatment with KEYTRUDA may increase the risk of rejection
in solid organ transplant recipients. Consider the benefit of treatment
with KEYTRUDA vs the risk of possible organ rejection in these patients.

KEYTRUDA can cause severe or life-threatening infusion-related
reactions, including hypersensitivity and anaphylaxis, which have been
reported in 6 (0.2%) of 2799 patients. Monitor patients for signs and
symptoms of infusion-related reactions, including rigors, chills,
wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever.
For Grade 3 or 4 reactions, stop infusion and permanently discontinue
KEYTRUDA.

Immune-mediated complications, including fatal events, occurred in
patients who underwent allogeneic hematopoietic stem cell
transplantation (HSCT) after being treated with KEYTRUDA. Of 23 patients
with cHL who proceeded to allogeneic HSCT after treatment with KEYTRUDA
on any trial, 6 patients (26%) developed graft-versus-host-disease
(GVHD), one of which was fatal, and 2 patients (9%) developed severe
hepatic veno-occlusive disease (VOD) after reduced-intensity
conditioning, one of which was fatal. Cases of fatal hyperacute GVHD
after allogeneic HSCT have also been reported in patients with lymphoma
who received a PD-1 receptor-blocking antibody before transplantation.
These complications may occur despite intervening therapy between PD-1
blockade and allogeneic HSCT. Follow patients closely for early evidence
of transplant-related complications such as hyperacute GVHD, severe
(Grade 3 to 4) acute GVHD, steroid-requiring febrile syndrome, hepatic
VOD, and other immune-mediated adverse reactions, and intervene promptly.

Based on its mechanism of action, KEYTRUDA (pembrolizumab) 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.

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11
percent of 370 patients with locally advanced or metastatic urothelial
carcinoma. The most common adverse reactions (in ≥ 20% of patients) were
fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%),
constipation (21%), rash (21%) and diarrhea (20%). Eighteen patients
(5%) died from causes other than disease progression. Five patients
(1.4%) who were treated with KEYTRUDA experienced sepsis which led to
death, and 3 patients (0.8%) experienced pneumonia which led to death.
Adverse reactions leading to interruption of KEYTRUDA occurred in 22% of
patients; the most common (≥1%) were liver enzyme increase, diarrhea,
urinary tract infection, acute kidney injury, fatigue, joint pain, and
pneumonia. Serious adverse reactions occurred in 42 percent of patients,
the most frequent (≥2%) of which were urinary tract infection,
hematuria, acute kidney injury, pneumonia, and urosepsis.

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8
percent of 266 patients with locally advanced or metastatic urothelial
carcinoma. The most common adverse reaction resulting in permanent
discontinuation of KEYTRUDA was pneumonitis (1.9%). Adverse reactions
leading to interruption of KEYTRUDA occurred in 20% of patients; the
most common (≥1%) were urinary tract infection (1.5%), diarrhea (1.5%),
and colitis (1.1%). The most common adverse reactions (≥20%) in patients
who received KEYTRUDA versus those who received chemotherapy were
fatigue (38% vs 56%), musculoskeletal pain (32% vs 27%), pruritus (23%
vs 6%), decreased appetite (21% vs 21%), nausea (21% vs 29%) and rash
(20% vs 13%). Serious adverse reactions occurred in 39 percent of
KEYTRUDA-treated patients, the most frequent (≥2%) of which were urinary
tract infection, pneumonia, anemia, and pneumonitis.

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 and for 4 months after the final dose.

Our Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology
medicines to help people with cancer worldwide. At Merck, 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.

As part of our focus on cancer, Merck is committed to exploring the
potential of immuno-oncology with one of the fastest-growing development
programs in the industry. We are currently executing an expansive
research program that includes nearly 500 clinical trials evaluating our
anti-PD-1 therapy across more than 30 tumor types. We also continue to
strengthen our immuno-oncology portfolio through strategic acquisitions
and are prioritizing the development of several promising
immunotherapeutic candidates with the potential to improve the treatment
of advanced cancers.

For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

About Merck

For over a century, Merck, a leading global biopharmaceutical company
known as MSD outside the United States and Canada, has been bringing
forward medicines and vaccines for many of the world’s most challenging
diseases. Through our prescription medicines, vaccines, biologic
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
health care through far-reaching policies, programs and partnerships.
Today, Merck continues to be on the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world – including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer’s disease and infectious
diseases including HIV and Ebola. For more information, visit www.merck.com
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respect to pipeline products that the products will receive the
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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

Patient Information/Medication Guide for KEYTRUDA at 

http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf

.



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