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domingo, 7 de agosto de 2016

KEYTRUDA Reaches Milestone for Recurrent or Metastatic Head and Neck Cancer Patients, FDA approval


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

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