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USFDA green lights Merck’s drug to treat advanced kidney cancer 

Merck announced it has got USFDA approval for its belzutifan drug, branded as Welireg, to treat an advanced form of kidney cancer.

HQ Team

December 15, 2023: Merck announced it got USFDA approval for its belzutifan drug, branded as Welireg, to treat an advanced form of kidney cancer.

The therapy for renal cell carcinoma is meant for patients who had prior treatment and the regulator’s nod was based on successful trials that proved “a statistically significant improvement in progression-free survival for patients randomized to WELIREG compared with everolimus,” according to a Merc statement.

Everolimus is manufactured by Novartis.

During the trial, Welireg reduced the risk of disease progression or death by 25% compared to everolimus in the 82-patient cohort, according to the statement.

Anaemia, haemorrhage

The median duration of exposure was 7.6 months for Welireg and 38% of the patients reported serious adverse reactions including, anaemia and haemorrhage.

Fatal adverse reactions occurred in 3.2% of the patients. Other adverse events included decreased haemoglobin, fatigue, musculoskeletal pain, increased creatinine, decreased lymphocytes, and decreased sodium levels.

Renal cell cancer is a disease in which malignant cells are found in the lining of tubules in the kidney. There are two kidneys, one on each side of the backbone, above the waist. Tiny tubules in the kidneys filter and clean the blood.

“This approval of belzutifan introduces a meaningful new treatment option for certain patients, as belzutifan reduced the risk of disease progression or death compared to everolimus,” said Dr Toni K. Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg professor of medicine, Harvard Medical School.

Boxed warning

The Welireg label contains a boxed warning that exposure to the drug during pregnancy could cause embryo-fetal harm.

Renal cell carcinoma is by far the most common type of kidney cancer — about 9 out of 10 kidney cancer diagnoses fall in this category.

Renal cell carcinoma is about twice as common in men than in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. About 15% of patients with kidney cancer are diagnosed at an advanced stage.

Merck is investigating the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumour types. It is looking for strategic acquisitions to improve the treatment of advanced cancers.


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