Otsuka has been granted a positive opinion from EU regulators for its subsidiary Taiho Pharmaceutical's new anti-cancer agent Teysuno.
The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use has recommended the approval of the drug as a first-line therapy for advanced gastric cancer when used in combination with cisplatin.
It comes on the back of a recent phase III clinical trial, Flags, in which a Teysuno-containing treatment regimen was shown to offer a comparable efficacy and safety profile compared to the control drug.
Should the treatment receive EMA approval as expected, it will mark the first regulatory clearance achieved by Teysuno outside of Japan and Asia.
Toru Usami, president of Taiho Pharmaceutical, said: "Teysuno is the first of what we hope will be many promising anti-cancer agents to be developed globally and made commercially available by Taiho."
Last month, Otsuka and Bristol-Myers Squibb announced positive clinical data from a trial of Sprycel, their treatment for Philadelphia chromosome-positive chronic myelogenous leukaemia.