NEW YORK (AP) – Novartis AG said that a panel of European Union regulators says its drug Afinitor should be approved to treat certain types of breast cancer.
The Committee for Medicinal Products for Human Use said Afinitor should be approved to treat advanced breast cancer in postmenopausal women whose cancer has recurred or progressed after previous treatment. It is recommending approval for Afinitor in hormone receptor-positive breast cancer, which accounts for about 75% of breast cancer cases. That type of breast cancer is more likely to respond to hormone therapy than other varieties.
Novartis said about 220,000 cases of hormone receptor-positive breast cancer are diagnosed worldwide every year.
The European Medicines Agency is not required to follow the recommendations of its panels, but it often does so. If it follows the recommendation, Afinitor will be approved as a breast cancer treatment in all 27 European Union countries, along with Iceland and Norway.
Afinitor is a pill taken once per day. It is approved as a treatment for cancers of the kidney and pancreas and for tuberous sclerosis, a rare genetic disorder which causes tumors in the brain, eyes, lungs, liver and other organs. The Food and Drug Administration is also reviewing Afinitor as a treatment for breast cancer.
A separate regulatory panel recommended that Novartis’ Seebri Breezhaler be approved as a treatment for chronic obstructive pulmonary disease. Novartis said it expects to file for marketing approval for that drug in the U.S. in 2014.
Date: June 22, 2012
Source: Associated Press
Filed Under: Drug Discovery