Novartis’ Afinitor recommended for breast cancer approval

Novartis has been granted a recommendation from a European Medicines Agency committee for approval of Afinitor as a new breast cancer treatment.

The Committee for Medicinal Products for Human Use (CHMP) has endorsed the use of Afinitor in combination with exemestane for the treatment of hormone receptor-positive, HER2/neu-negative advanced breast cancer.

Afinitor has been trialled among postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor in the phase III trial Bolero-2, during which it demonstrated a strong efficacy and safety performance.

The European Commission generally follows the opinion of the CHMP and is expected to deliver its verdict within three months of this recommendation.

Herve Hoppenot, president of Novartis Oncology, said: "The committee's support of Afinitor brings us one step closer to providing an important new option for women living with this disease."

Last week, the company reported positive data from a phase III trial of Gilenya, showcasing the drug's efficacy against relapsing forms of multiple sclerosis.