After the Oasmia Pharmaceutical’s pivotal study OAS 07OVA conducted on ovarian cancer patients with disease relapse, showed that the risks of disease progression or death after Apealea treatment in combination with carboplatin are similar as after comparator; CrEL-formulated paclitaxel in combination with carboplatin, the European Commission has granted an approval of Apealea for treatment of adult patients.
Oasmia Pharmaceutical said Thursday that Apealea was approved for treating adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer in combination with Carboplatin. As the company noted, this approval marks the first approval for a systemic platinum-based paclitaxel combination therapy approved for first relapse of platinum-sensitive epithelial ovarian cancer.
Furthermore noted, the European Commission has granted a centralized marketing authorization with unified labelling that is valid in 28 countries of the European Union (EU), as well as the European Economic Area members, Iceland, Lichtenstein and Norway.
“Today’s milestone for Apealea is an important one for patients in Europe experiencing a relapse of their ovarian cancer disease since this treatment allows a platinum-based treatment option with a high dose paclitaxel free from Cremophor EL (CrEL),” the company said in its press release.