Merck's Cancer Drug Welireg Granted Priority Review by FDA

By Colin Kellaher

The U.S. Food and Drug Administration (FDA) has given priority review status to Merck & Co.'s application seeking expanded approval for its cancer drug, Welireg, in patients with the most common type of kidney cancer.

Application Covers Advanced Renal Cell Carcinoma

The application submitted by the New Jersey-based pharmaceutical company, Merck, covers the use of Welireg in adults with advanced renal cell carcinoma following prior immune checkpoint and anti-angiogenic therapies.

Priority Review Designation

The FDA grants priority review to medications that have the potential to significantly improve the treatment of serious diseases. This designation shortens the review period, aiming to accelerate the availability of promising treatments. In this case, the FDA has set a target action date of January 17, 2024, for Merck's application.

Prevalence of Renal Cell Carcinoma

Renal cell carcinoma is responsible for approximately 90% of kidney cancer cases. It is estimated that 15% of patients in the United States are diagnosed at an advanced stage.

Previous Approval for Welireg

Welireg was previously approved by the FDA for certain adults with von Hippel-Lindau disease, who require therapy for associated renal cell carcinoma, central-nervous-system hemangioblastomas, or pancreatic neuroendocrine tumors.

Strong Sales Performance for Welireg

Merck has reported first-half sales of Welireg amounting to $92 million, which is more than double the sales from the same period last year.