FDA approves belzutifan for VHL kidney cancer

The FDA has approved a new drug called belzutifan for people with von Hippel-Lindau (VHL) disease and renal cell carcinoma (RCC), CNS hemangioblastomas, or pancreatic neuroendocrine tumours (pNETS) who do not need surgery immediately. Belzutifan is a hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. Kidney cancers frequently have mutations in a gene called the von Hippel-Lindau (VHL) gene, resulting in […]

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FDA approves pembrolizumab plus lenvatinib combination for advanced kidney cancer

The US Food and Drug Administration (FDA) has approved the combination of pembrolizumab, an anti-PD-1 immunotherapy, plus lenvatinib, an oral tyrosine kinase inhibitor, for the first-line treatment of people with advanced renal cell carcinoma (RCC). The approval is based on the results from the phase 3 CLEAR/KEYNOTE-581 trial, in which the combination showed significant improvement […]

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FDA grants priority review for HIF-2α inhibitor belzutifan (MK-6482)

The US Food and Drug Administration (FDA) has granted priority review for a marketing license for the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, belzutifan. Belzutifan is a new medicine for the treatment of patients with von Hippel-Lindau (VHL) renal cell carcinoma (RCC) who do not need surgery immediately. Kidney cancers frequently have mutations in a gene called the […]

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Cabozantinib plus nivolumab granted FDA approval for first-line treatment of advanced kidney cancer

The Food and Drug Administration (FDA) in the United States has approved the cabozantinib (Cabometyx) plus nivolumab (Opdivo) combination for first-line treatment of advanced renal cell carcinoma (RCC) based on the results of the Checkmate 9ER trial. Around 20-30% of people are diagnosed with advanced RCC, and 30% of people treated for early stage RCC go on […]

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Ilixadencel granted Regenerative Medicine Advanced Therapy by FDA for metastatic kidney cancer

The US Food and Drug Administration (FDA) has designated ilixadencel a Regenerative Medicine Advanced Therapy (RMAT) as a treatment for metastatic renal cell carcinoma (RCC). This designation is similar to the FDA’s Breakthrough Therapy Designation, and recognises the therapeutic potential of ilixadencel as well as the unmet patient need for viable therapies for this difficult-to-treat […]

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Generic everolimus approved by the FDA

The US Food and Drug Administration (FDA) has approved generic everolimus tablets for the treatment of patients with various advanced cancers, including renal cell carcinoma (RCC). Afinitor comes off patent over the next 5 years, after which generic everolimus will become available at a vastly cheaper cost to the NHS. A generic drug is a pharmaceutical drug that contains […]

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Avelumab plus axitinib granted FDA approval for advanced kidney cancer

The Food and Drug Administration (FDA) in the United States has approved the avelumab (Bavencio) plus axitinib (Inlyta) combination for first-line treatment of advanced renal cell carcinoma (RCC). The approval is the first by the FDA for an anti-PD-L1 therapy as part of a combination treatment for patients with advanced RCC. Around 20-30% of people […]

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Pembrolizumab plus axitinib granted FDA approval for advanced kidney cancer

The Food and Drug Administration (FDA) in the United States has approved the pembrolizumab (Keytruda) plus axitinib (Inlyta) combination for first-line treatment of advanced renal cell carcinoma (RCC). The approval comes two months earlier than expected and is based on the results from the open-label KEYNOTE-426 study involving 861 patients. In this study, median progression-free […]

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Synthetic or plant-based cannabis for symptom relief in patients with cancer

This article discusses the evidence available for synthetic and plant-based cannabis for the treatment of people with cancer. The article is very much from a US perspective, where public demand has increased awareness of cannabis as a potential therapeutic option for cancer patients. However, this awareness has also highlighted some complex medical, financial and legal concerns. This controversy […]

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FDA grants Fast Track designation to glutaminase inhibitor combination for metastatic kidney cancer

The glutaminase inhibitor, CB-839 has been granted Fast Track designation by the US Food and Drug Administration (FDA) in combination with cabozantinib (Cabometyx) for the treatment of people with metastatic renal cell carcinoma (mRCC) who have previously received one or two drug treatments. The FDA’s Fast Track programme speeds up the development, review and approval […]

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