Novartis' ambitions for Afinitor suffer on liver-cancer failure

It's a new blow for Novartis' ($NVS) Afinitor hopes. After failing to win backing in breast cancer from U.K. cost-effectiveness gurus, the drug fell short in a liver cancer trial. As the Swiss drugmaker announced today, the study found that Afinitor didn't prolong patients' lives any better than placebo.

Afinitor is one of the newer drugs Novartis has staked its future on, and so far, it has delivered: Since its approval in 2009 for kidney cancer, Afinitor sales have taken major leaps every year, from $243 million in 2010 to $797 million last year. So far this year, the drug has churned up $611 million, putting it on track to break the blockbuster barrier by year's end.

But Novartis' growth strategy for the drug depends on adding new indications, and the company has spent big money to do so. It has racked up several new uses, and it now is approved to treat kidney cancer, a rare type of pancreatic cancer, advanced breast cancer, rare childhood brain tumors and benign tumors caused by tuberous sclerosis. Its new breast-cancer indication alone could add as much as $1.5 billion to peak sales.

Liver cancer could have been another big addition. Now dominated by Bayer's Nexavar, the market for liver cancer drugs is expected to surpass $2 billion by 2015.

Novartis says it's disappointed with the new study, which looked at patients with advanced liver cancer who either couldn't tolerate Nexavar or whose cancers had stopped responding to that drug. But the company will press on, said Alessandro Riva, global head of oncology development. "Novartis remains committed to studying everolimus through a robust research and development program to address unmet needs in different types of cancer," Riva said in a statement.

Currently, the Swiss drugmaker is studying the drug against gastrointestinal and lung tumors, HER2-positive breast cancer, lymphoma and tuberous sclerosis complex, with results of those trials coming next year and in 2015.

- read the announcement from Novartis

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