Impact Therapeutics (HKG:7630) said the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Senaparib as a maintenance treatment for advanced ovarian, fallopian tube and primary peritoneal cancer.
The recommendation is based mainly on results from the Phase III FLAMES trial, the company said in a Friday Hong Kong bourse filing. The drug will now be submitted to the European Commission for a final decision. If approved, Senaparib will be authorized for marketing across European Union member states and European Economic Area countries.