Merck Drug Gets FDA Approval as a First-Line Lung Cancer Treatment
25 October 2016 - 12:40PM
Dow Jones News
Merck & Co.'s immunotherapy cancer drug Keytruda received
U.S. Food and Drug Administration approval as a first-line
treatment for certain lung cancer patients.
The approval is for patients with metastatic non-small cell lung
cancer whose tumors have high PD-L1 expression, with no EGFR or ALK
genomic tumor aberrations.
The new indication means Keytruda can be an initial treatment
instead of chemotherapy for these patients.
Additionally, the FDA approved a Keytruda labeling update for
second-line treatment for certain patients, reflecting favorable
data from the Keynote-010 trial.
Keytruda, or pembrolizumab, was first approved in 2014 for the
treatment of melanoma. The Keytruda clinical development program
includes more than 30 tumor types.
In October 2015, the drug was cleared for use as a second-line
treatment for certain patients with non-small-cell lung cancer
whose disease continued to worsen after the patient received
chemotherapy or other drugs.
A Merck study published earlier this month showed that people
who received Keytruda as their first treatment lived longer on
average than those who received chemotherapy.
In a separate study of another immunotherapy drug, Bristol-Myers
Squibb Co.'s Opdivo failed to significantly prolong survival beyond
chemotherapy. Bristol-Myers tested Opdivo as a first-line treatment
in a broader pool of lung cancer patients because the study also
included those who had relatively low levels of PD-L1 in their
tumors.
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
October 24, 2016 21:25 ET (01:25 GMT)
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