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Jul 5, 2011

Positive Trial Data Leads Novartis to Plan Breast Cancer Filing for Afinitor by Year End

  • Adding Novartis’ Afinitor® (everolimus) to exemestane therapy against advanced breast cancer significantly improves progression-free survival compared with exemestane therapy alone, according to interim Phase III trial data. Novartis says it plans worldwide regulatory submissions for the drug as a treatment for estrogen receptor-positive, locally advanced, or metastatic breast cancer, by the end of 2011.

    The global Bolero-2 study included over 700 postmenopausal women with estrogen receptor-positive locally advanced or metastatic breast cancer whose disease had progressed despite initial treatment with the nonsteroidal aromatase inhibitors letrozole or anastrozole. The trial was stopped early after the positive interim data showed everolimus plus exemestane extended time without tumor growth.

    Everolimus is approved in the EU for the treatment of advanced renal cell carcinoma (RCC) in patients whose disease has progressed after treatment with VEGF-targeting therapy. In the U.S. and Switzerland the drug is approved for the advanced RCC indication after the failure of either sunitinib or sorafenib treatment. Clearance of everolimus in the U.S. for treating subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS), covers use of the drug in patients who require therapeutic intervention but aren’t candidates for curative surgical resection.

    In May Switzerland also approved everolimus for the SEGA associated with TS indication in patients aged three years and over who are not candidates for surgery. In June the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approving everolimus for the treatment of SEGA associated with TS.   

    Afinitor was cleared by FDA for treating progressive neuroendocrine tumors of pancreatic origin (pancreatic NET) in patients with unresectable, locally advanced or metastatic disease in May. Regulatory applications in the EU and other markets are also in progress for use of the drug against carcinoid tumors, an indication for which FDA has ruled that the safety and effectiveness of everolimus hasn’t been established.

    Everolimus is separately approved in the U.S for the prevention of organ rejection in adult kidney transplant patients, and in Europe for preventing organ rejection in heart and kidney transplant patients.

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