FDA Approves Belzutifan for Patients With Advanced Renal Cell Carcinoma

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The FDA has approved belzutifan to treat patients with advanced renal cell carcinoma (RCC) who have already undergone PD-1 or PD-L1 inhibitor and a VEGF tyrosine kinase inhibitor.

FDA Approves Belzutifan for Patients With Advanced Renal Cell Carcinoma

FDA Approves Belzutifan for Patients With Advanced Renal Cell Carcinoma

The FDA has approved belzutifan (Welireg) to treat patients with advanced renal cell carcinoma who have already undergone treatment with both a PD-1 or PD-L1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).1

Findings from the LITSPEAK-005 trial (NCT014195750) supported the regulatory decision. This was an open-label, randomized, head-to-head trial that enrolled 749 patients with unresectable locally advanced or metastatic clear cell RCC who had already received either both a PD-1/PD-L1 checkpoint inhibitor and a VEGF/TKI.

Ultimately, those who received belzutifan experienced a statistically significant improvement in progression-free survival (PFS) compared with those who received everolimus (Afinitor; HR, 0.75; 95% CI, 0.63-0.90; 1-sided p-value = .0008). The estimated median progression-free survival was 5.6 months (95% CI, 3.9-7.0) vs 5.6 months (95% CI, 4.8-5.8), respectively.

Moreover, although overall survival results were immature at data cutoff, and only 59% of deaths had been reported, investigators did not observe a trend towards OS detriment.

The recommended dose for belzutifan is 120 mg orally each day until either disease progression or unacceptable toxicity occurs.

In the trial, the most common adverse events that patients experienced were decreased hemoglobin, fatigue, musculoskeletal pain, increased creatinine, decreased lymphocytes, increased alanine aminotransferase, decreased sodium, increased potassium, and increased aspartate aminotransferase.

Belzutifan is also approved for adult patients with von Hippel-Lindau disease.2

According to the prescribing label, it is important that providers verify their patients’ pregnancy status prior to initiating treatment, as it can cause significant embryo-fetal harm. Patients should be taught about the value of effective non-hormonal contraception, as the anticancer medication can render some hormonal contraceptives ineffective.

Other warnings included on the label are for anemia and hypoxia. Providers should monitor for anemia prior to treatment initiation and periodically throughout treatment. Should anemia occur, the agent should be withheld until hemoglobin surpasses 9 g/dL, and then either resumed at a reduced dose or discontinued.

Providers should also monitor oxygen saturation prior to initiating and throughout treatment with belzutifan. If hypoxia at rest develops, it should be withheld until resolved, resumed at a dose, or discontinued depending on severity.

Reference

  1. FDA approves belzutifan for advanced renal cell carcinoma. FDA. December 14, 2023. Accessed December 14, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-advanced-renal-cell-carcinoma?utm_medium=email&utm_source=govdelivery
  2. Welireg. Prescribing information. Merck & Co, Inc; 2021; Accessed December 14, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215383s000lbl.pdf
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