CHMP Issues Positive Opinion For Merck and Endocyte's VYNFINIT

Merck and partner Endocyte announced the positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the Conditional Marketing Authorization of VYNFINIT (vintafolide).

The CHMP positive opinion extends to VYNFINIT’s companion imaging components imaging agent FOLCEPRI (etarfolatide) and NEOCEPRI (intravenous (IV) folic acid) as treatment of adult patients with folate receptor-positive, platinum-resistant, ovarian cancer combined with with pegylated liposomal doxorubicin (PLD). Vintafolide is proposed for use in combination with PLD to treat adult patients while etarfolatide and IV folic acid are medicines proposed for diagnostic use only.

Ron Ellis, Endocyte’s president and CEO, said “Vintafolide is a folate receptor targeted agent, and if approved, would be the first oncology therapeutic to employ an imaging agent as a companion diagnostic for patient selection. Today’s positive CHMP opinions are an important step toward personalizing ovarian cancer management for appropriate patients, and validate our Company’s focus on the development of targeted medicines and companion imaging agents designed to improve patient outcomes.”

Ovarian cancer is considered one of the most lethal cancers of the female reproductive system. In the EU alone, over 40,000 new cases of ovarian cancer were estimated in 2012. Approximately 80 percent of patients experience relapse after first-line, platinum-based chemotherapy.

Dr. Eric Rubin, vice president of Clinical Development for Oncology at Merck Research Laboratories, said “These positive CHMP opinions bring Merck and Endocyte one step closer to providing a personalized approach to address a significant unmet medical need in platinum-resistant ovarian cancer. We want to acknowledge our colleagues at Endocyte for their pioneering work in this field, and look forward to the European Commission completing their review of the applications.”

The application for Conditional Marketing Authorization for vintafolide, etarfolatide and IV folic acid was based on positive results from the PRECEDENT Phase 2 study. If approved, the European Commission will grant a centralized marketing authorization with unified labeling that is valid in 28 member countries of the European Union as well as European Economic Area members.