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news.New Jersey-based Bayer HealthCare Pharmaceuticals’ investigational compound regorafenib has been granted orphan drug status by the US Food and Drug Administration to treat patients with gastrointestinal stromal tumours (GIST).
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Bayer HealthCare Executive Committee member and head of global development Kemal Malik said that this was an important step in the overall development process for this investigational compound.
The primary endpoint of the placebo-controlled phase III study of regorafenib is progression-free survival.
Secondary endpoints include overall survival, time to progression, disease control rate, tumour response rate, duration of response, and safety.
All patients will enter the Survival Follow-Up Period upon discontinuation of study treatment, during which assessment of survival status will be performed every three months.