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EMA Accepts For Review MAA Filings For Vintafolide And Etarfolatide

Merck & Co. Inc. (MRK), and Endocyte Inc. (ECYT), announced that the European Medicines Agency has accepted for review the marketing authorization application filings for the investigational cancer candidate vintafolide and investigational companion diagnostic imaging agent etarfolatide, for the targeted treatment of patients with folate-receptor positive platinum-resistant ovarian cancer in combination with pegylated liposomal doxorubicin. Both vintafolide and etarfolatide have been granted orphan drug status by the European Commission.

The MAA filings are supported by four clinical studies: a Phase I study in solid tumors, two single-agent, single-arm Phase II studies in ovarian cancer and non-small cell lung cancer, and the PRECEDENT trial, a randomized Phase IIb study in patients with platinum-resistant ovarian cancer. The application is being submitted for conditional approval on the basis that the results from the Phase II studies fulfill an unmet medical need.

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