FDA Approves Merck's Keytruda for Lung Cancer
October 02 2015 - 3:00PM
Dow Jones News
The U.S. Food and Drug Administration approved Merck & Co.'s
Keytruda for the treatment of the most common form of lung cancer,
the second in a new wave of immune-boosting drugs to be cleared for
one of the deadliest cancer types.
The FDA also approved a companion diagnostic from Dako North
America, which tests for a substance on tumor cells known as PD-L1,
to screen for patients who should receive Merck's Keytruda. A
Merck-funded study found that Keytruda worked better in patients
with higher levels of PD-L1 than in patients with lower or
undetectable levels.
Merck shares declined 1.4% on the news because the FDA
requirement that Keytruda should be used in PD-L1-positive patients
could limit the population of patients using the drug.
Keytruda now joins rival Bristol-Myers Squibb Co.'s Opdivo as a
new treatment option for certain patients with non-small cell lung
cancer, which accounts for about 85% to 90% of all lung-cancer
cases. The FDA approved Opdivo to treat a subtype of lung cancer in
March and is expected to decide by January whether to expand
Opdivo's use to a wider group of lung-cancer patients.
Both Keytruda and Opdivo work by blocking a substance on immune
cells known as PD-1, lifting a natural brake on the immune system
and allowing it to kill cancer cells. Doctors believe the anti-PD-1
drugs have potential to transform treatment of multiple tumor
types, based on clinical trials showing improvements in survival
and tumor-shrinkage rates versus some older treatments.
Analysts estimate the class has multibillion-dollar sales
potential—fueled by hefty prices. Keytruda and Opdivo both cost
about $12,500 a month per patient, or $150,000 if used for a full
year.
On Thursday, the FDA approved the use of a combination of Opdivo
and an older Bristol immunotherapy, Yervoy, for the treatment of
melanoma. The treatment would cost about $256,000 for the first
full year.
Write to Peter Loftus at peter.loftus@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
October 02, 2015 14:45 ET (18:45 GMT)
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