The U.S.
The
drug combination is intended for use in women with recurrence or progression of
their cancer after treatment with Femara (letrozole) or Arimidex (anastrozole).
“This is the first approval from the class of
drugs known as mTOR inhibitors for the treatment of postmenopausal women with
advanced hormone-receptor positive breast cancer,” said Richard Pazdur, M.D.,
director of the Office of Hematology and Oncology Products in the FDA’s Center
for Drug Evaluation and Research. “Afinitor is another example of the value of
continuing to study drugs in additional types of cancer after their initial approval.”
The
FDA has previously approved Afinitor to treat patients with advanced renal cell
carcinoma that has 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 require treatment
but are not candidates for curative surgery.
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