European regulators approves Novartis drug Afinitor to treat women with certain breast cancers
Swiss drug maker Novartis AG says it has received European approval to market Afinitor for treatment of women with the most common form of advanced breast cancer.
Afinitor is already approved to treat various tumors of the pancreas, kidney and brain.
The U.S. Food and Drug Administration approved the pill-based drug earlier this month for use in combination with Aromasin for postmenopausal women with recurring hormone receptor positive breast cancer lacking the protein HER2.
Novartis said Monday that the European Commission’s approval was based on a trial of more than 700 patients showing those treated with the two drugs lived significantly longer before their disease progressed.
The company said recently its annual sales of Afinitor could rise above the $1 billion mark with the new approvals.
The drug is the first in a class known as mTOR inhibitors to be approved for post-menopausal women with advanced hormone-receptor positive, HER2-negative breast cancer. American health regulators also backed the drug as a breast cancer treatment.
Afinitor, also known as everolimus, is designed to be given in combination with another drug, Aromasin, to treat women whose cancer has recurred or progressed after treatment with two other therapies. Aromasin is made by Pfizer Inc.
Novartis’s drug is already approved to treat patients with four other types of cancer, including kidney and a rare type of pancreatic cancer.
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GENEVA