The German Institute for Quality and Efficiency in Health Care (IQWiG) has published a report which concludes that an additional benefit for Kisplyx (lenvatinib) in combination with everolimus for the treatment of advanced renal cell carcinoma (RCC, or kidney cancer) versus the established comparator therapy - as defined by the Federal Joint Committee (G-BA) - has been proven.
The final decision to implement the report's recommendation lies with the G-BA and is expected for March 2017, noted the drug’s maker, Japanese pharma major Eisai (TYO 4523), which also pointed out that around 15,000 people in Germany develop renal cell carcinoma every year.
Eisai´s request for an accelerated assessment was agreed by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on November 19, 2015 as the product was considered to be of major public health interest. In August 2016, the European Commission issued the marketing authorization for lenvatinib in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF)-targeted therapy.
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