The US Food and Drug Administration (FDA) have granted Breakthrough Therapy Designation for the multiple receptor tyrosine kinase inhibitor, lenvatinib (Kisplyx) in combination with the anti-PD-1 therapy, pembrolizumab (Keytruda) for the treatment of patients with advanced and/or metastatic renal cell carcinoma (RCC).

The breakthrough therapy designation speeds up the development and review of medicines that target serious or life-threatening conditions and have the potential to offer substantial benefit over existing therapies. The FDA awarded breakthrough therapy status based on a preliminary evaluation of clinical data from Study 111, a multicentre, open-label phase Ib/II clinical study being carried out in the United States and Europe to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab in various solid tumours.

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