AVASTIN NOT APPROVED BY EMEA FOR GLIOBLASTOMA

The current indication should not be extended to include the use of bevacizumab alone or in combination with irinotecan in patients with glioblastoma (WHO Grade IV malignant glioma) after relapse

At its meeting on 19 November 2009, the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted negative opinion, recommending that Oncophage (vitespen), from Antigenics Therapeutics Ltd. should not be granted a marketing authorisation. Oncophage was expected to be used as an adjuvant treatment for localised renal cell carcinoma (RCC) patients at increased risk of recurrence with the following features: primary tumour stage T1b or T2 with high grade (3 or 4) histology with no nodal involvement. Oncophage was designated as an orphan medicine for renal cell carcinoma on 11 April 2005. The application for the marketing authorisation for Oncophage was submitted to the Agency on 29 September 2008 and on 26 October 2009, the EMEA has been formally notified by Antigenics Therapeutics Limited of its decision to withdraw its application for a centralised marketing authorisation for the Oncophage, 20 μg solution for infusion. In its official letter, the company stated that the withdrawal of the application was based on the CHMP’s view that the information submitted is not sufficient to demonstrate efficacy of Oncophage at this point in time.

The Committee adopted positive opinions for a number of generic medicines:

• Docetaxel TEVA (docetaxel), from Teva Pharma B.V., a generic of Taxotere, which is authorised in the European Union for the treatment of breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer.
• Temozolomide Teva (temozolomide), from Teva Pharma B.V., and Temomedac (temozolomide), from Alfred E. Tiefenbacher GmbH & Co. KG, generics of Temodal, which is authorised in the EU for treatment of glioblastoma and malignant glioma.

The Committee adopted a negative opinion for Avastin (bevacizumab), from Roche Registration Ltd, recommending that the current indication should not be extended to include the use of the medicine alone or in combination with irinotecan in patients with glioblastoma (WHO Grade IV malignant glioma) after relapse.

The Committee recommended that the contraindication for pregnant and breast-feeding women should be deleted from the product information for Taxotere (docetaxel) and Docetaxel Winthrop (docetaxel), both from Aventis Pharma S.A..

The Committee also concluded a re-examination of its previous negative opinion on an application for an extension of indication for Erbitux (cetuximab), from Merck KgaA, confirming its negative opinion that the indication of Erbitux should not be extended to add the first–line treatment of patients with epidermal growth factor receptor (EGFR) – expressing advanced or metastatic non-small cell lung cancer in combination with platinum-based chemotherapy.