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 The drug was approved for use as a monotherapy, as well as in
combination with a common chemotherapy regimen, to treat previously
untreated patients with head and neck squamous cell carcinoma, Merck
said.
The approval is based on results from a late-stage trial, where
Keytruda showed a significant improvement in overall survival in
cancer patients, Merck said.
Keytruda, a type of immunotherapy called a PD-1 inhibitor, is
already an approved treatment for several forms of cancer, including
lung and skin cancers.
Head and neck cancer includes tumors in the mouth, tongue, nose,
sinuses, throat and lymph nodes in the neck.
Merck estimates that there will be more than 65,000 new cases of
head and neck cancer diagnosed in 2019 in the United States.
Keytruda works by increasing the ability of patients' immune system
to help detect and fight tumor cells.
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The drug has been amassing approvals as a standalone therapy and in
combination with other drugs to treat several forms of cancer. It is
the leading immunotherapy for treating lung cancer, ahead of rival
drugs from Bristol-Myers Squibb, Roche and AstraZeneca.
Keytruda, first approved for advanced melanoma in 2014, is Merck's
most important growth driver. It has overtaken Bristol's Opdivo as
the industry's immuno-oncology leader with sales expected to top $10
billion this year and $20 billion in 2024, according to IBES data
from Refinitiv.
Keytruda brought in revenue of $7.17 billion for Merck in 2018,
while Bristol's Opdivo earned $6.74 billion.
(Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by
Shailesh Kuber)
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