EMA/CHMP backs approval of Merck ovarian cancer drug Vynfinit and companion diagnostics

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for US pharma giant Merck & Co (NYSE: MRK) and partner Endocyte’s (Nasdaq: ECYT) Vynfinit (vintafolide) for the treatment of women with a subtype of platinum-resistant ovarian cancer for which there is limited approved treatment option.

The CHMP has also recommended two companion diagnostic medicines, Folcepri (etarfolatide) and Neocepri (folic acid) that will help identify patients who will benefit from a treatment with Vynfinit.

The recommendation for the approval of Vynfinit, together with Folcepri and Neocepri, all of which are designated orphan medicines, illustrates the current trend towards the development of medicines targeted at specific patient populations, which is based on a better understanding of the underlying molecular mechanisms of the disease, the EMA noted. By targeting specific patient groups who are likely to better respond to a treatment, the response rate in the population treated can be improved and treatment can be avoided in patients who are unlikely to respond to the treatment, sparing them potential side effects.