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 The drug, which blocks a mechanism tumors use to hide from the
immune system allowing it to recognize and attack the cancer, won
accelerated U.S. approval last August for these patients based on
its ability to shrink tumors.
As a condition of the accelerated approval, Merck was required to
conduct a trial to demonstrate superiority over standard treatment
and verify the clinical benefit of Keytruda in this patient
population.
Despite the failure to improve survival, Merck said the current
approval still stands. The U.S. drugmaker said it will continue a
Phase III trial of Keytruda as an initial treatment for patients
with advanced head and neck cancers.
It is a second rare setback for the medicine seen as the leading
treatment among immunotherapies from the same class, known as PD-1
or PD-L1 inhibitors. Earlier this month, Keytruda trials in the
blood cancer multiple myeloma were stopped due to more deaths among
those who received Keytruda along with standard combination therapy
than those on standard treatment alone.
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Keytruda is also approved for advanced melanoma, non-small cell lung
cancer, advanced bladder cancer and classical Hodgkin lymphoma. In
May, Keytruda became the first drug to win U.S. approval based on a
patient's specific genetic traits, regardless of where in the body
the cancer originated, known as microsatellite instability-high
cancer.
Merck shares fell about 1 percent to $61.99 in extended trading from
a New York Stock Exchange close at $62.57.
(Reporting by Bill Berkrot; Editing by Lisa Shumaker)
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