The Avastin medicine has largely lived up to its billing as an innovative way to attack tumors, along the way generating the most revenue for any cancer drug while being Roche Holding AG’s best-selling treatment with 6.46 billion Swiss francs ($6.88 billion) in sales last year.
Only now are the limitations of Avastin, introduced in 2004, becoming clear to doctors. Even before US regulators in December moved to revoke the drug’s conditional approval for treating breast cancer, Kent Osborne, a Texas oncologist, said in an interview that he was reducing use of the drug, citing its “huge” costs, disappointing benefits and frequent side effects.
“We’re talking about breast cancer that has spread and our job here, since we can’t cure patients yet, is to palliate them,” said Osborne, director of Baylor College of Medicine’s cancer center in Houston. “If you have a drug that makes their quality of life worse, you haven’t accomplished that goal.”
Avastin, developed by Roche’s Genentech unit, is the first commercial medicine to capitalize on a theory, first proposed 40 years ago, that tumor growth can be stopped by turning off a cancer cell’s access to blood. Studies show Avastin, in combination with chemotherapy, can extend life about five months in patients with advanced colorectal tumors. Still, the drug has failed to live up to early expectations that it would forestall death for years in patients with cancer that has spread.
Peak sales
In 2009, Bill Burns, then the head of pharmaceuticals at Basel, Switzerland-based Roche, said the drug’s annual sales might reach as much as 9 billion Swiss francs by this year. Three weeks ago, however, Roche Chief Executive Officer Severin Schwan said the drug’s sales may now only reach 7 billion francs.
Avastin’s failure to win full US Food and Drug Administration approval against breast cancer — a market estimated by researcher GlobalData to have been valued at $8.7 billion in 2009 — is muting enthusiasm for Avastin, which works by deactivating a chemical known as vascular endothelial growth factor, or VEGF, which spurs blood-vessel growth. The drug’s poor record against early-stage cancers, and survival gains of only a few months for most patients with advanced cancer, are additional reasons for the slowing sales growth.
‘Brilliant concept’
“The last time Avastin appeared to be a ‘revolutionary’ treatment was when it was a laboratory idea,” Leonard Saltz, a research oncologist at Memorial Sloan-Kettering Cancer Center in New York, said in an interview. “Stopping the blood supply to a tumor is a brilliant concept, but in my opinion we have not really succeeded in bringing it to fruition in clinical trials.”
As doctors get a better sense of Avastin’s limits, governments in Europe and US insurers are questioning its annual cost of as much as $100,000. The UK’s National Institute for Health and Clinical Excellence in London has refused to recommend the drug for any tumor type. The agency, which advises the UK National Health Service on cost-effective treatments, is carrying out additional reviews of the drug. “Scientifically it’s a very important discovery, but in the clinic it hasn’t been as significant as we thought it would be,” said Lee Newcomer, an oncologist and vice president at Minnetonka, Minnesota-based UnitedHealth Group Inc, the biggest US health insurer by revenue. Newcomer said his view of the drug is based on journal studies and on the FDA’s statements.
‘Removal of growth’
Roche shares have fallen 9.2 per cent since July 16, when an FDA staff review concluded the follow-up trials of Avastin against breast cancer weren’t as positive as earlier tests. The stock rose 60 centimes, or 0.4 per cent, to 137.6 francs at 10:33 am in Zurich trading.
“Clearly a lot of the premium that Roche had attracted was based on Avastin growing and the removal of that growth does put the consensus ‘buy’ case much more at risk,” said Amit Roy, an analyst at Nomura International in London. “It removes the critical driver for the stock and from an investment point of view, people are struggling to get excited about this story.”
Sales of Avastin may have peaked in 2010 and may fall to about 5.7 billion francs by 2013, according to Roy, who has a price target of 130 francs.
The FDA said on December 16 that it was starting the process to rescind Avastin’s accelerated approval granted in 2008 for use against breast tumors.
