Therapy Areas: Oncology
FDA to review Xspray Pharma's Dasynoc for market approval
13 January 2022 -

Swedish pharmaceutical company Xspray Pharma AB (STO:XSPRAY) said on Thursday that the US Food and Drug Administration (FDA) has agreed to review the company's application for market approval for its product candidate Dasynoc (dasatinib).

This application consists of the results from registrational studies on healthy volunteers, where bioequivalence was achieved at an approximately 30% lower dosage than the reference product Sprycel. The application includes Dasynoc for the treatment of acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML), which are blood cancer illnesses in an area where only one new drug has been registered over a ten-year period, the company said.

Subject to approval from the FDA, Xspray Pharma estimates that Dasynoc could be launched in the US market in 2023.