KEYTRUDA Reaches Milestone for
Recurrent or Metastatic Head and Neck Cancer Patients
Dear Oncology team:
Today’s U.S. Food and Drug
Administration approval of KEYTRUDA for previously treated patients with
recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) is an
important advance for a difficult-to-treat and complex disease. As the first
anti-PD-1 therapy approved for HNSCC – and the first new treatment of any kind
approved for this cancer in a decade – KEYTRUDA will bring HNSCC patients whose
disease has progressed following other therapies a desperately needed new
option, and most importantly, new hope.
Head and neck cancer is the seventh
most common cancer in the world, with nearly 62,000 new cases expected to be
diagnosed in the United States in 2016. Recognizing the high unmet need for
these patients, the FDA made this decision based on data from KEYNOTE-012 under
the accelerated approval program.
KEYNOTE-012 is the first clinical study to investigate the role of a
PD-1 inhibitor in recurrent or metastatic HNSCC. You can read more about the
results of KEYNOTE-012 in the press release. Importantly, the study showed
similar durability of response to what we’ve seen in other KEYTRUDA trials.
Today’s news is another
significant milestone in the journey of KEYTRUDA and we’re not done yet. Our
head and neck cancer immuno-oncology clinical development program is the
largest in the industry. This research brings us closer to understanding
HNSCC’s historically high recurrence rate and poor long-term outcomes. To learn
more about what this news means for HNSCC patients, make sure to read the piece
from Dr. Jonathan Cheng, executive director, Oncology Clinical Development, on
Merck.com.
I’m extremely proud of the
great work and dedication that brought us to this noteworthy approval. We still
have much to learn about treating HNSCC, but we are a step closer, with even
more promising paths to uncover. I hope you take time to consider what your
hard work means to those living with this terrible disease, and use that to
motivate you as we continue to bring KEYTRUDA to as many patients as possible.
Spectacular job, team.
Regards,
Jill DeSimone
Senior Vice President, U.S.
Commercial Operations, Oncology
Copyright © 2001-2016 Merck & Co., Inc.,
Kenilworth, NJ, U.S.A. All rights reserved.
Dear Oncology team:
Today’s U.S. Food and Drug
Administration approval of KEYTRUDA for previously treated patients with
recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) is an
important advance for a difficult-to-treat and complex disease. As the first anti-PD-1
therapy approved for HNSCC – and the first new treatment of any kind approved
for this cancer in a decade – KEYTRUDA will bring HNSCC patients whose disease
has progressed following other therapies a desperately needed new option, and
most importantly, new hope.
Head and neck cancer is the
seventh most common cancer in the world, with nearly 62,000 new cases expected
to be diagnosed in the United States in 2016. Recognizing the high unmet need
for these patients, the FDA made this decision based on data from KEYNOTE-012
under the accelerated approval program.
KEYNOTE-012 is the first clinical study to investigate the role of a
PD-1 inhibitor in recurrent or metastatic HNSCC. You can read more about the
results of KEYNOTE-012 in the press release. Importantly, the study showed
similar durability of response to what we’ve seen in other KEYTRUDA trials.
Today’s news is another
significant milestone in the journey of KEYTRUDA and we’re not done yet. Our
head and neck cancer immuno-oncology clinical development program is the
largest in the industry. This research brings us closer to understanding
HNSCC’s historically high recurrence rate and poor long-term outcomes. To learn
more about what this news means for HNSCC patients, make sure to read the piece
from Dr. Jonathan Cheng, executive director, Oncology Clinical Development, on
Merck.com.
I’m extremely proud of the
great work and dedication that brought us to this noteworthy approval. We still
have much to learn about treating HNSCC, but we are a step closer, with even
more promising paths to uncover. I hope you take time to consider what your
hard work means to those living with this terrible disease, and use that to
motivate you as we continue to bring KEYTRUDA to as many patients as possible.
Spectacular job, team.
Regards,
Jill DeSimone
MSD - Senior Vice President,
U.S. Commercial Operations, Oncology
