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Meeting highlights from the European Medicines Agency Committee for Medicinal Products for Human Use, 18-21 October 2010
28.10.10
Category: Scientific News
Positive opinions for generic medicines and extension of therapeutic indications for ibandronic acid, topotecan, docetaxel, dasatinib, and sunitinib

At its October meeting, the European Medicines Agency Committee for Medicinal Products for Human Use adopted positive opinions, recommending the granting of marketing authorizations for the following generic medicines:
• Iasibon (ibandronic acid), from Pharmathen S.A., for the prevention of skeletal events in patients with breast cancer and bone metastases, and for the treatment of tumor-induced hypercalcaemia with or without metastases. Iasibon is a generic of Bondronat.
• Potactasol (topotecan), from Actavis Group PTC ehf, for the treatment of metastatic carcinoma of the ovary, small cell lung cancer and carcinoma of the cervix. Potactasol is a generic of Hycamtin.
• Docetaxel Teva Pharma (docetaxel), from Teva Pharma B.V., for the treatment of locally advanced or metastatic breast cancer and small cell lung cancer, and of metastatic prostate cancer. Docetaxel Teva Pharma is a generic of Taxotere.
The Committee gave also positive opinions for applications for extensions of the therapeutic indications, adding new treatment options for medicines that are already authorized in the European Union, for:
• Sprycel (dasatinib), an orphan medicine from Bristol-Myers Squibb Pharma EEIG, to include the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in the chronic phase.
• Sutent (sunitinib), from Pfizer Ltd, to include the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors with disease progression in adults.