Novartis halted a trial of Afinitor in advanced breast cancer patients because the drug had already met its goal of extending the time period before tumors began to grow again. Armed with this new data--which the company plans to present at an upcoming conference--Novartis plans to ask regulators later this year for approval to market Afinitor for breast cancer.
Already approved to treat several other cancers in the U.S. and Europe, Afinitor works by blocking a protein that fuels cancer growth. It racked up sales of $243 million last year--three times its 2009 sales--but analysts expect the drug to soar to blockbuster status if it can gain approval in breast cancer. The company is also testing Afinitor in breast cancer patients with HER2-positive disease.
This latest study comprised more than 700 women and tested Afinitor in combination with the estrogen inhibitor exemestane compared with exemestane plus placebo. The company said that Afinitor "significantly" extended the time without tumor growth. "Despite clinical progress in advanced breast cancer, most women are either initially resistant or develop resistance to [hormonal] therapy over time," Herve Hoppenot, Novartis oncology president, said in a statement. "Based on these study results, this combination has the potential to extend the time until chemotherapy is needed for these patients."
Vontobel analyst Andrew Weiss told Dow Jones that if Novartis persuades regulators to grant the new indication--which he gives a 40 percent chance of success--its sales for that use would peak at around $1.8 billion. "The breast-cancer indication is the most important for the Afinitor franchise," he told the news service. Other analysts figure on $1.5 billion, Reuters said. Either way, the growth for Afinitor would be a big help in offsetting Novartis revenues lost to patent expirations over the next few years, including the blood pressure blockbuster Diovan.
ALSO: The FDA has scolded Novartis for a meningitis vaccine promotion the agency said was "false and misleading" for implying that its use was consistent with guidelines from an influential U.S. vaccinations panel. Report