US FDA approves Merck's drug for kidney cancer

Send a link to a friend  Share

[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.

[to top of second column]

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)

[© 2023 Thomson Reuters. All rights reserved.]This material may not be published, broadcast, rewritten or redistributed.  Thompson Reuters is solely responsible for this content.

Back to top