Everolimus approved by EMEA for the second line treatment of advanced RCC after progression despite treatment with VEGF-targeted therapy
Extended indication for pemetrexed to include monotherapy maintenance treatment of locally advanced or metastatic NSCLC in patients whose disease has not progressed immediately following platinum-based chemotherapy
At the May, 2009 the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of a marketing authorisation, for the following medicines:
Everolimus for the second line treatment of advanced renal cell carcinoma in patients whose disease has progressed despite treatment with vascular endothelial growth factor (VEGF)-targeted therapy.
Everolimus displays anti-neoplastic activity by inhibiting the mTOR protein kinase pathway, thus inhibiting cell growth, proliferation and survival. This pathway is also involved in angiogenesis, also decreased by everolimus treatment which inhibits the vascular endothelial growth factor receptor.
Everolimus treatment achieves the prolongation of progression free survival by about 3 months. Patients may experience stomatitis/mucositis, infections, cytopenias, rash and similar events, metabolic, renal, pulmonary or hepatic events, bleeding and thromboembolic events as the most common side effects. It is advised that treatment be made by a physician with experience in anticancer therapies.
The CHMP reviewed the quality, safety and efficacy data and determined a favorable benefit to risk balance exists, therefore granting the marketing authorization. The review finished 206 days after inception on 23 July 2008.
Plerixafor is intended for use in patients whose cells mobilize poorly, for example, patients with lymphoma and multiple myeloma. Plerixafor is to be administered in a 20 mg/ml solution together with granculocyte –colony stimulating factor (G-CSF) to achieve greater hematopoietic stem cell mobility into the peripheral blood for collection and subsequent autologous transplantation.
The benefit of this therapy is an increase in the number of patients who reach the target number of cell mobilization as compared to treatment with G-CSF alone.
Common side effects include diarrhea, nausea and injection site redness or irritation. Administration of plerixafor is to be carried out by a physician with experience in oncology and/or hematology in an appropriate onco-hematology center with monitoring capabilities.
The review time was 207 days. This agent achieved orphan medicinal product status on 20 October 2004.
The Committee gave positive opinions for applications for the extension of indication, adding a new treatment option, for the following medicines:
Pemetrexed to include monotherapy maintenance treatment of locally advanced or metastatic non-small cell lung cancer in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed is already authorised in this indication as monotherapy for second-line treatment after prior chemotherapy, and as first line treatment in combination with cisplatin. It is also authorised as combination therapy for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.
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