FDA to Review Merck Drug as First-Line Treatment for Lung Cancer
September 07 2016 - 2:42PM
Dow Jones News
The U.S. Food and Drug Administration will review Merck &
Co.'s immunotherapy cancer drug Keytruda as a first-line treatment
for patients with the most common form of lung cancer, the company
said Wednesday.
The FDA granted Keytruda, or pembrolizumab, breakthrough therapy
designation and priority-review status with a target action date of
Dec. 24.
In October, Keytruda was cleared for use as a second-line
treatment in patients with non-small-cell 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. Merck is now seeking approval for the drug as a
stand-alone treatment option.
Merck's latest submissions were based on data from a pivotal
phase 3 Keynote-024 study released in June, which showed that
Keytruda monotherapy resulted in superior progression-free survival
as well as overall survival compared with standard chemotherapy.
The trial was stopped early so patients still on chemotherapy could
opt to start treatment with Keytruda.
"Chemotherapy has been the foundation of first-line treatment
for non-small cell lung cancer for decades, so the significant
improvement in survival in patients with high PD-L1 expression seen
with Keytruda compared to chemotherapy is welcome news," said Dr.
Roger Perlmutter, Merck's research chief.
Keytruda, an infused drug, was first 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. It was granted breakthrough status for specific patients
with advanced melanoma, metastatic non-small-cell lung cancer in
previously treated patients, microsatellite instability high
metastatic colorectal cancer, and relapsed or refractory classical
Hodgkin lymphoma.
Merck shares, inactive premarket, have risen 20% so far this
year.
Write to Anne Steele at Anne.Steele@wsj.com
(END) Dow Jones Newswires
September 07, 2016 14:27 ET (18:27 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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