26 July 2016 - The EMA's definition of a new medicine is a very liberal one.

Last week, the CHMP recommended granting marketing authorisations in the European Union for two medicines for the treatment of advanced renal cell carcinoma. Cabometyx (cabozantinib maleate) and Kisplyx (lenvatinib mesylate) are indicated for the treatment of adult patients with advanced renal cell carcinoma who have been previously treated with a vascular endothelial growth factor-inhibitor; Cabometyx is to be used as monotherapy while Kisplyx is for use in combination with everolimus.  The EMA press release states they are 'new medicines'.

The reality is that both are not new medicines.  Cabozantinib maleate (Cometriq) was approved by the European Commission on 21 March 2014 for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma. Lenvatinib mesylate (Lenvima) was a;proved by the European Commission on 28 May 2015 for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine. The recent CHMP outcomes should be classified as new indications. 

The classification of these outcomes as new medicines inflates the number of true new medicines the EMA will recommend/approve this calendar year.  Cabozantinib maleate and lenvatinib mesylate are not the examples for 2016.