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Everolimus Approval for Advanced Breast Cancer

TON - AUGUST 2012 VOL 5, NO 7 published on August 23, 2012 in FDA Updates

The FDA approved everolimus (Afinitor; Novartis Pharmaceuticals Corporation) for use in combination with exemestane to treat postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer who experienced treatment failure with letrozole or anastrozole. The approval was granted on July 20, 2012.

Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, commented that everolimus “is another example of the value of continuing to study drugs in additional types of cancer after their initial approval.” Everolimus had previously received approval to treat patients with advanced renal cell carcinoma that had progressed after treatment with other cancer therapies, in adult patients with progressive advanced neuroendocrine tumors of pancreatic origin, for patients with renal angiomyolipoma and tuberous sclerosis complex (TSC) not requiring immediate surgery, and for adults and children with subependymal giant cell astrocytoma associated with TSC who were not candidates for curative surgery but who required treatment.

FDA approval was based on the results of a randomized, double-blind, multicenter trial involving 724 patients who had experienced menopause, had estrogen receptor–positive, HER2-negative breast cancer that had spread, and had previously received treatment with letrozole or anastrozole. Patients received either everolimus plus exemestane or placebo plus exemestane.

Median progression-free survival was 7.8 months for patients in the everolimus plus exemestane arm and 3.2 months in the placebo plus exemestane arm. An interim analysis of overall survival was not statistically significant; a final analysis is expected in June 2014.

Mouth ulcers, infections, rash, fatigue, diarrhea, and decreased appetite were the most common side effects observed in patients in the trial who received everolimus. Patients aged 65 years and older experienced a higher rate of serious side effects than did younger patients.

For the Record

In the June issue of The Oncology Nurse-APN/PA, the im - provement in overall survival (OS) and radiographic progression- free survival (PFS) data presented in the Androgen Blockers Score Big in Prostate Cancer news brief was incorrect. With respect to enzalutamide, the improvement in OS is 4.8 and the improvement in PFS is 5.4 compared with placebo. We apologize for the error.

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Last modified: April 27, 2020