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EMA Recommends Granting a Marketing Authorisation for Apealea (Paclitaxel)

It is indicated in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer
24 Sep 2018
Gynaecologic malignancies;  Anticancer agents & Biologic therapy

On 20 September 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Apealea (paclitaxel), intended for the treatment of ovarian cancer. 

The applicant for this medicinal product is Oasmia Pharmaceutical AB. 

Apealea will be available as a 60 mg powder for solution for infusion. The active substance of Apealea is paclitaxel, an antineoplastic agent that belongs to the taxanes class (ATC code: L01CD01). Paclitaxel blocks a stage of cell division in which the cell’s internal ‘skeleton’ is dismantled to allow the cell to divide. By keeping this structure intact the cells cannot divide and they eventually die. Apealea also affects non-cancer cells such as blood and nerve cells, which can cause side effects. 

The benefit with Apealea is its ability to improve progression-free survival in combination with carboplatin

The most common side effects are neutropenia, gastrointestinal disorders, peripheral neuropathy, arthralgia/myalgia, and infusion site reactions. 

The full indication is: 

Apealea, in combination with carboplatin, is indicated for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. 

It is proposed that Apealea be prescribed by physicians experienced in the use of anticancer therapies. 

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission. 

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

Last update: 24 Sep 2018

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