GSK submits variation to MAA with EU and sNDA with US FDA for Votrient to treat sarcoma
GlaxoSmithKline (GSK) announced that it has submitted a variation to the Marketing Authorisation Application to the European Medicines Agency for Votrient (pazopanib) for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy, or for patients who are unsuited for such therapy.
Additionally, GSK announced that it has submitted a supplemental New Drug Application to the US Food and Drug Administration for Votrient for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy.
The phase III soft tissue sarcoma trial population excluded patients with adipocytic soft tissue sarcoma (liposarcoma) or gastrointestinal stromal tumour.
According to a GSK press release, Votrient is not approved or licensed anywhere in the world for the treatment of advanced soft tissue sarcoma.
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