The US Food and Drug Administration has given marketing approval to Afinitor, a drug made by Novartis, for the treatment of post-menopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.
Afinitor—known by the generic name everolimus—becomes the first drug in its class to be approved for this patient population. Afinitor is in the class of drugs called mTOR inhibitors. It received marketing approval last month as well from the European Medicines Agency for the same treatment within the same patient population.
Afinitor is currently FDA approved as a treatment for patients with several different types of cancer:
- Advanced renal cell carcinoma
- Brain tumors
- Pancreatic cancers
- Breast cancers
Approval from the FDA comes on the heels of a trial of 724 advanced stage breast cancer patients. The trial demonstrated that Afinitor plus Aromasin on average gave patients progression-free survival of 7.8 months compared to a progression-free survival of 4.6 months in patients receiving Aromasin plus a placebo.
"This approval redefines the treatment and management of advanced hormone receptor-positive breast cancer, offering a critical new option for physicians and patients," said Dr. Gabriel Hortobagyi,one of the investigators for the pivotol trial.
Source: FDA
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