Adjuvant pembrolizumab gets positive opinion from the European CHMP

We have just learnt that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), is recommending approval of pembrolizumab for the adjuvant treatment of people with intermediate to high risk renal cell carcinoma (RCC) following nephrectomy. The CHMP positive opinion will now be reviewed by the […]

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European Commission approves pembrolizumab plus lenvatinib as first-line treatment for advanced kidney cancer

The European Commission 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) for use within the European Union (including Northern Ireland). The approval is based on the results from the phase 3 CLEAR/KEYNOTE-581 trial, in which […]

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Nivolumab/cabozantinib combination approved in EU for first-line kidney cancer treatment

The European Commission has approved the use of the nivolumab plus cabozantinib combination for the first-line treatment of people with advanced renal cell carcinoma (RCC). The combination is now licensed for use within the European Union. The Medicines and Healthcare products Regulatory Agency (MHRA) will need to approve the nivolumab plus cabozantinib combination before it […]

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European Commission approves avelumab plus axitinib combination for the first-line treatment of advanced kidney cancer

Based on the findings from the pivotal phase III JAVELIN Renal 101 study, the European Commission has approved avelumab in combination with axitinib for the first-line treatment of advanced renal cell carcinoma (RCC). JAVELIN Renal 101 demonstrated that avelumab in combination with axitinib significantly lowered risk of disease progression or death by 31% and nearly […]

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European Commission approves pembrolizumab plus axitinib combination for first-line treatment of advanced kidney cancer

Based on the findings from the pivotal phase 3 KEYNOTE-426 trial, the European Commission has today approved pembrolizumab (anti-PD-1 therapy) in combination with axitinib (tyrosine kinase inhibitor) for patients with untreated, advanced renal cell carcinoma (RCC). The KEYNOTE-426 trial demonstrated a reduced risk of death by 47% with the combination compared to sunitinib in patients […]

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European Commission approves cabozantinib for first-line kidney cancer

The European Commission has approved cabozantinib (Cabometyx) for the first-line treatment of advanced renal cell carcinoma (RCC).  The approval is based on data from the CABOSUN trial, which demonstrated that cabozantinib significantly prolongs progression-free survival (PFS) compared to sunitinib in people with untreated advanced RCC at intermediate or poor-risk of the cancer spreading. Cabozantinib, a […]

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