Novartis is celebrating after getting another thumbs-up from regulators in the USA for Afinitor, this time as a treatment for advanced breast cancer.
The US Food and Drug Administration has approved Afinitor (everolimus) for use in combination with Pfizer's Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer. Specifically, the combo is intended for use in women with recurrence or progression of their cancer after treatment with Novartis' own Femara (letrozole) or AstraZeneca's Arimidex (anastrozole).
The agency has previously approved Afinitor, an mTOR inhibitor, to treat advanced renal cell carcinoma that has progressed after treatment with other cancer therapies, for progressive advanced neuroendocrine tumours of pancreatic origin and for patients with renal angiomyolipoma and tuberous sclerosis complex (TSC) not requiring immediate surgery. It is also available for subependymal giant cell astrocytoma associated with TSC.
Novartis quoted Gabriel Hortobagyi at the University of Texas MD Anderson Cancer Center, as saying 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". He added that the approval "redefines the treatment and management of advanced hormone receptor-positive breast cancer, offering a critical new option".
This latest approval is likely to provide a major boost to the already-healthy sales of Afinitor, which recently received a recommendation for approval in Europe for breast cancer. The drug brought in $175 million in the second quarter, up 72%.