FDA Approves Merck's Kidney Cancer Drug For Rare Type Of Neuroendocrine Tumors

Vandana Singh

Wed, May 14, 2025, 12:17 PM 2 min read

The U.S. Food and Drug Administration (FDA) connected Wednesday approved Merck & Co. Inc.’s (NYSE:MRK) Welireg (belzutifan) for big and pediatric patients 12 years and older with locally advanced, unresectable, oregon metastatic pheochromocytoma oregon paraganglioma (PPGL).

This represents the archetypal FDA support of an oral therapy for PPGL, rare neuroendocrine tumors that tin dispersed to different parts of the body.

Welireg received support from the FDA and European Medicines Agency for big patients with precocious renal compartment carcinoma (RCC).

Also Read: Merck’s Q1 Earnings Beat Wall Street, Adjusts 2025 Profit Outlook As Tariffs May Result In Incremental Cost Of $200 Million

Efficacy was evaluated successful LITESPARK-015, an open-label, multi-cohort trial.

The large efficacy result measurement was nonsubjective effect complaint (ORR). Additional efficacy result measures were duration of effect (DOR) and the fig of patients who had a simplification successful astatine slightest 1 antihypertensive medicine by astatine slightest 50%, maintained for astatine slightest six months.

• ORR was 26%.

• Median DOR was 20.4 months.

• Of the 60 patients connected baseline antihypertensive medications, 19 (32%) had a simplification successful astatine slightest 1 antihypertensive medicine by astatine slightest 50% for astatine slightest six months.

The recommended belzutifan dose for adults is 120 mg administered orally erstwhile daily.

The recommended dose for pediatric patients 12 years and older is based connected assemblage weight. For pediatric patients weighing ≥ 40 kg, the dose is 120 mg orally erstwhile daily.

For pediatric patients weighing < 40 kg, the dose is 80 mg orally erstwhile daily.

In the archetypal 4th of 2025, Welireg generated income of $137 million, 62% twelvemonth implicit year.

Price Action: MRK banal is down 3.45% astatine $73.98 at the past cheque connected Wednesday.

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