CHMP positive for Apealea to treat ovarian cancer.- Oasmia Pharma

Oasmia Pharmaceutical AB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Apealea (paclitaxel water-soluble formulation) in combination with carboplatin for treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. The CHMP considers that the product Apealea in combination with carboplatin has a positive benefit-risk balance and is considered approvable for the above-mentioned indication.

The CHMP recommendation is based on clinical trials including the pivotal study OAS 07OVA. This study showed that the risks of disease progression or death after Apealea treatment in combination with carboplatin are similar as after Cremophor EL (CrEL)-formulated paclitaxel in combination with carboplatin.

Comment: Standard treatment of ovarian cancer is Taxol in combination with carboplatin. Taxol is a combination of paclitaxel, Cremophor EL (polyethoxylated castor oil) and ethanol. In order to avoid hypersensitivity reactions to Cremophor EL, treatment with Taxol requires extensive pre-medication with corticosteroids and antihistamines as well as a long infusion time. In the recently published results from Oasmia's pivotal Phase III study, Paclical/ Apealea showed a positive risk/benefit profile compared to treatment with Taxol; no need for pre-medication, the infusion time is one hour and possibly a reduced risk of experiencing neuropathy.