FDA Suspends Certain Clinical Trials of Merck's Keytruda
July 05 2017 - 6:55PM
Dow Jones News
By Peter Loftus
The U.S. Food and Drug Administration suspended two clinical
trials and a portion of a third testing Merck & Co.'s Keytruda
as a treatment for blood cancer, after more patients receiving the
drug died than those receiving other treatments, the company
said.
Merck said Wednesday the FDA determined the risks of Keytruda,
when added to the other drugs the patients in the trial were
taking, outweighed any potential benefit for patients with the
blood cancer multiple myeloma, based on available data. The other
drugs used in the studies are Celgene Corp.'s Pomalyst and
Revlimid.
An FDA spokeswoman couldn't immediately be reached to
comment.
Merck said all patients in two of the studies and a portion of
those in a third study will stop receiving Keytruda. Other studies
of Keytruda will continue, including among multiple myeloma
patients, Merck said.
Merck is conducting more than 400 clinical trials to test new
uses for Keytruda, which is already FDA-approved to treat multiple
cancer types including those of the skin and lungs. The drug,
introduced in the U.S. in 2014, works by harnessing the body's
immune system to attack tumors.
Merck first disclosed the increased patient death rate last
month, saying it had paused enrollment for new patients in two of
the multiple myeloma studies, based on a recommendation by an
external committee monitoring the safety of patients. At that time,
Merck said it would allow patients already enrolled in those
studies to continue receiving Keytruda.
The third study affected by the FDA suspension tested Keytruda
in combination with a variety of older drugs to treat multiple
myeloma. A subset of patients receiving Keytruda in combination
with Revlimid and another drug, dexamethasone, will discontinue
Keytruda treatment, but Keytruda's use among other patients in the
study will continue.
A Merck spokeswoman said the company had no further details
about the patient deaths in the studies.
Keytruda had sales of $1.4 billion in 2016, which are expected
to grow this year as the drug has been approved for additional
uses, including to treat any tumor with a certain genetic
mutation.
Merck shares fell 1% to $63.50 in after-hours trading after it
announced the FDA action. In regular trading, the stock fell 0.17%
to $64.16 Wednesday.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
July 05, 2017 18:40 ET (22:40 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
Merck (NYSE:MRK)
Historical Stock Chart
From Aug 2024 to Sep 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Sep 2023 to Sep 2024