Sunday, February 9, 2025

WELIREG Receives FDA Approval for Advanced Renal Cell Carcinoma Treatment

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WELIREG, a drug designed for adult patients with renal cell carcinoma (RCC), has been approved by the FDA. This approval comes after the drug’s use following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

The FDA’s approval is based on the significant and clinically meaningful results from the LITESPARK-005 trial. This trial is unique for being the only one in advanced RCC to specifically analyze patients who have progressed after a PD-1 or PD-L1 inhibitor and a VEGF-TKI.

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Superior Outcomes for Advanced Renal Cell Carcinoma Patients

The LITESPARK-005 study showed that WELIREG has superior progression-free survival (PFS) compared to everolimus in advanced RCC after treatment with both a PD-1 or PD-L1 checkpoint inhibitor and a VEGF receptor targeted therapy, either administered in sequence or combination. Additionally, WELIREG demonstrated an objective response rate (ORR) of 22% compared to 4% for everolimus, indicating a much higher rate of effectiveness.

Last year, WELIREG was approved as the first HIF-2α inhibitor therapy in the U.S. for the treatment of adult patients with certain VHL disease-associated tumors. It is now also approved for eligible patients with advanced RCC.

This approval of WELIREG signifies the introduction of the first new therapeutic class for advanced RCC patients in nearly a decade. This was based on the significant progression-free survival benefits observed in patients following treatment with a PD-1 or PD-L1 inhibitor and a VEGF-TKI compared to everolimus.

Renal Cell Carcinoma

WELIREG’s Approval Marks a Turning Point in Advanced Kidney Cancer Care

RCC is the most prevalent type of kidney cancer, with men being twice as likely to contract it than women. About 15% of kidney cancer patients are diagnosed at an advanced stage, making effective treatments like WELIREG crucial.

The approval of WELIREG for advanced RCC treatment marks a significant milestone in RCC care. This drug, which has shown superior effectiveness compared to everolimus, offers a new therapeutic class for RCC patients who have not seen improvements with other treatments. This approval comes at a crucial time, as RCC remains the most prevalent type of kidney cancer, and many patients are diagnosed at an advanced stage where effective treatments are desperately needed.


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