Lenvatinib plus pembrolizumab combination designated a breakthrough therapy by the FDA

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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