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December 15, 2023
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FDA approves Welireg for adults with advanced kidney cancer

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The FDA approved belzutifan for treatment of adults with advanced renal cell carcinoma.

The indication applies to individuals who experienced disease progression after treatment with a PD-1 or PD-L1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor.

Generic FDA News infographic
Belzutifan had a superior overall response rate compared with everolimus.

Patients receiving belzutifan (Welireg, Merck) had a 25% drop in disease progression and death compared with those treated with everolimus (HR = 0.75; 95% CI, 0.63-0.9), based on the results of the phase 3 LITESPARK-005 trial.

Belzutifan also conferred a superior overall response rate (22% vs. 4%), complete response rate (3% vs. 0%) and partial response rate (19% vs. 4%) compared with everolimus.

“This approval is exciting news for our patients, as it gives us a new option for refractory patients with kidney cancer,” Toni K. Choueiri, MD, director of the Lank Center for Genitourinary Cancer at the Dana-Farber Cancer Institute, said in a press release. “Belzutifan is an oral drug with a novel mechanism of action that reduced risk [for] disease progression or death and had favorable quality of life in this patient population, when compared to everolimus.”

In the randomized trial of 746 patients, participants either received 120 mg of belzutifan or 10 mg of everolimus.

Serious adverse reactions occurred in 38% of patients receiving belzutifan, including hypoxia (7%), anemia (5%), pneumonia (3.5%), hemorrhage (3%) and pleural effusion (2.2%). Fatal adverse reactions occurred in 3.2% of study participants.

Common adverse reactions included fatigue, musculoskeletal pain, increased levels of creatinine, alanine aminotransferase, potassium and aspartate aminotransferase, and decreased hemoglobin, lymphocyte and sodium levels.

Other adverse reactions included hemorrhage (9%) rash (8%), hypertension (6%), visual impairment (6%) and increased weight (5%).

Adverse reactions caused 6% of patients to stop using belzutifan, 39% had treatment interruptions and 13% required dose reductions.

Clinicians prescribing belzutifan should give patients 120 mg orally once daily “until disease progression or unacceptable toxicity,” the FDA stated in its press release.

The prescribing information for belzutifan warns that the agent can cause harm to an embryo or fetus and advises physicians verify a woman’s pregnancy status before use.

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