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US FDA approves Merck's drug for kidney cancer

Published 12/14/2023, 06:02 PM
Updated 12/15/2023, 12:11 PM
© Reuters. 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

(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 (SIX:NOVN)' 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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