FDA Breakthrough designation for Lenvima and Keytruda combo

Japanese pharma major Eisai (TYO: 4523) and US giant and Merck & Co (NYSE: MRK), have received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for Eisai's multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib) in combination with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma (RCC).

The Lenvima (marketed as Kisplyx for RCC in the European Union) and Keytruda combination therapy is being jointly developed by Eisai and Merck under a March 2015 agreement. This is the second Breakthrough Therapy designation for Lenvima and the 12th granted to Keytruda. This Breakthrough Therapy designation was based on the results of the RCC cohort in Study 111, a multicenter, open-label Phase Ib/II clinical study being carried out in the USA and the European Union to evaluate the efficacy and safety of Lenvima in combination with Keytruda in subjects with selected solid tumors.

Lenvima is also approved as a combination therapy for adults with advanced or metastatic RCC - alongside Novartis' mTOR inhibitor Afinitor (everolimus) - in patients who have previously been treated with at least one VEGF-targeted therapy.”