Posted by Michael Wonder on 23 Nov 2018
Oasmia Pharmaceutical receives approval from European Commission for Apealea (paclitaxel micellar) in the European Union
22 November 2018 - Apealea is approved in the European Union for treatment of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer in combination with carboplatin in first relapse.
Oasmia Pharmaceutical AB today announce that the European Commission has granted an approval of Apealea for treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer in combination with carboplatin. This approval marks the first approval for a systemic platinum-based paclitaxel combination therapy approved for first relapse of platinum-sensitive epithelial ovarian cancer.
The European Commission decision is based on clinical trials including the pivotal study OAS 07OVA conducted on patients with disease relapse.
