FDA to Review Merck's Keytruda for Head and Neck Cancer
April 13 2016 - 8:50AM
Dow Jones News
The U.S. Food and Drug Administration has accepted Merck &
Co.'s supplemental biologics license application for its
immunotherapy cancer drug for patients with head and neck cancer,
the pharmaceutical company said Wednesday.
The FDA granted pembrolizumab, or Keytruda, priority review
status with a target action date of Aug. 9.
Keytruda, an infused drug, was approved in 2014 for the
treatment of melanoma. Then, it was a new type of immunotherapy, in
a category of treatments that harness the immune system to fight
cancer. In October, it cleared for use in patients with
non-small-cell lung cancer—the most common form of lung
cancer—whose tumors contain a certain level of a protein known as
PD-L1, and whose disease continued to worsen after the patient
received chemotherapy or other drugs.
Pembrolizumab was the first so-called PD-1 inhibitor to hit the
U.S. market. The drugs block a protein called programmed death
receptor 1, or PD-1, which acts as a brake on certain immune-system
cells to prevent them from attacking healthy tissue. Cancer cells
can escape destruction by latching onto PD-1; PD-1 inhibitors block
this interaction at the site of the tumor, releasing the immune
system brake and allowing it to destroy the cancer.
Merck is now seeking approval for the treatment of patients with
recurrent or metastatic head and neck squamous cell carcinoma with
disease progression on or after platinum-containing
chemotherapy.
"Starting in the early days of our development program, we have
explored the role of Keytruda for patients with head and neck
cancer, a difficult-to-treat and debilitating disease with very few
treatment options," said Dr. Roger Dansey, senior vice president
and therapeutic area head of oncology late-stage development at
Merck Research Laboratories. "We are encouraged by the data
emerging from our program in this type of cancer."
Write to Anne Steele at Anne.Steele@wsj.com
(END) Dow Jones Newswires
April 13, 2016 08:35 ET (12:35 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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