Novartis’ Afinitor Approved for Breast Cancer by FDA

Novartis announced on Friday that they have received approval from US regulators for Afinitor as a treatment for advanced breast cancer.

The US Food and Drug Administration (FDA) have given the thumbs up to Afinitor (everolimus) for use with Pfizer’s Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.  The combination is proposed for use in women with recurrence or progression of their cancer after treatment with Novartis’ own Femara (letrozole) or AstraZeneca’s Arimidex (anastrozole).

The FDA have previously approved Afinitor, an mTOR inhibitor, to treat advanced renal cell carcinoma that has progressed post-treatment from other cancer therapies, for progressive advanced neuroendocrine tumours of pancreatic origin and for patients with renal angiomyolipoma and tuberous sclerosis complex not needing immediate surgery.  Afinitor is also obtainable for subependymal giant cell astrocytoma associated with tuberous sclerosis complex.

Gabriel Hortobagyi, from the University of Texas MD Anderson Cancer Center, noted that Afinitor is “the first and only treatment that boosts the effectiveness of endocrine therapy, significantly extending the time women with advanced breast cancer live without tumour progression.”  Hortobagyi added that the approval “redefines the treatment and management of advanced hormone receptor-positive breast cancer, offering a critical new option.”

“Afinitor is another example of the value of continuing to study drugs in additional types of cancer after their initial approval,” commented Dr. Richard Pazdur, head of the Food and Drug Administration’s cancer drugs office.

Breast cancer is the second leading cause of cancer-related death among women, after lung cancer.  This year, a projected 226,870 people will be diagnosed with breast cancer – approximately 40,000 of them with advanced breast cancer – and 39,510 will die from the disease.

A late-stage clinical trial of 724 women demonstrated that those who received Afinitor plus Aromasin on average had 7.8 months before their cancer got worse, which is a 4.6 month improvement over people just receiving Aromasin with a placebo, the US Food and Drug Administration noted.

Cancer is an progressively significant therapeutic area for Novartis, which faces tough competition from Roche Holding AG, the world leader in oncology.

The latest approval is expected to deliver a major lift to the already-healthy sales of Afinitor, which recently received recommendation for approval in Europe for breast cancer.  The drug took $175 million in the second quarter, an increase of 72%.


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