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Novartis to submit Afinitor for approval

Novartis is to submit its advanced breast cancer drug Afinitor for marketing approval following positive results from a phase III study

Novartis is to submit its advanced breast cancer drug Afinitor (everolimus) for marketing approval following positive results from a phase III study.

The BOLERO-2 was stopped early after interim results showed that the primary end point of significant progression-free survival compared to placebo plus exemestane had already been met.

The study involved postmenopausal women with estrogen receptor-positive locally-advanced or metastatic breast cancer, whose disease has progressed, despite initial endocrine therapy.

Hervé Hoppenot, president, Novartis Oncology, described how woman can develop resistance to endocrine therapy, and that there is a "significant need" for new treatment options.

He said: "Based on these study results, this combination has the potential to extend the time until chemotherapy is needed for these patients."

Novartis has said it will present the results at an upcoming medical conference, with plans for regulatory approval submission to be submitted by the end of 2011.

5th July 2011

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