Drug News

FDA Approves Merck’s Welireg (Belzutifan) for Renal Cell Carcinoma Treatment

In a significant development, the U.S. Food and Drug Administration (FDA) granted approval on Thursday for Merck’s drug belzutifan, marketed as Welireg, to be used in the treatment of renal cell carcinoma in patients who have undergone prior treatments.

Renal cell carcinoma is a form of cancer characterized by the presence of cancer cells in the lining of small tubes within the kidney.

The approval of Welireg was supported by compelling data obtained from a late-stage clinical trial. The results demonstrated a statistically significant and clinically meaningful enhancement in progression-free survival (PFS) compared to Novartis’ drug, everolimus.

Progression-free survival, a key metric in cancer treatment, indicates the duration a patient lives without the disease progressing after receiving treatment. The positive outcomes observed in the late-stage trial suggest that Welireg has the potential to offer an improved therapeutic option for patients with renal cell carcinoma.

It’s noteworthy that Welireg had previously received approval in 2021 for the treatment of cancers associated with Von Hippel-Lindau Disease. This rare genetic disorder is characterized by the growth of non-cancerous tumors in specific parts of the body.

Merck’s Welireg, with its expanding range of approvals, underscores its growing significance in the field of oncology and marks a positive step forward in the efforts to address various forms of cancer. The approval also provides renewed hope for patients with renal cell carcinoma who have exhausted previous treatment options.


Joan David-Leonhard

Joan David Leonhard is a recent Pharm.D graduate with a strong passion for the pharmaceutical industry and a particular interest in pharmaceutical media and communication. Her brief internship experience includes roles in pharmacy where she built strong patient-pharmacist relationships and a pharmaceutical media internship where she actively contributed to drug information articles, blog posts, social media engagement, and various media projects.
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