US FDA approves Merck's drug for kidney cancer
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[December 15, 2023]
(Reuters) -The U.S. Food and Drug Administration on Thursday
approved Merck's drug belzutifan for a type of kidney cancer.
The drug, branded as Welireg, is used to treat patients with renal cell
carcinoma who have received prior treatment.
Renal cell carcinoma is a disease in which cancer cells are found in the
lining of very small tubes in the kidney.
Welireg's approval is based on data from a late-stage trial, where the
drug showed statistically significant and clinically meaningful
improvement in progression-free survival (PFS) of patient compared to
Novartis' drug, everolimus.
PFS refers to how long a patient lives without the disease getting worse
after treatment.
In 2021, the drug was approved for cancers associated with Von
Hippel-Lindau Disease, a rare, genetic disorder in which non-cancerous
tumors grow in certain parts of the body.
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Signage is seen outside of the Food and Drug Administration (FDA)
headquarters in White Oak, Maryland, U.S., August 29, 2020.
REUTERS/Andrew Kelly/File photo
 (Reporting by Christy Santhosh;
Editing by Maju Samuel)
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