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July 16 (Bloomberg) -- Roche Holding AG’s top-seller Avastin didn’t slow breast
tumors in new studies as much as in earlier tests used to win approval,
according to U.S. regulators weighing whether to permit sales to continue for
Avastin paired with chemotherapy didn’t help patients survive longer than use of
the other drugs alone, and those receiving the Roche medicine had more serious
side effects, according to a Food and Drug Administration staff review today.
FDA advisers will meet July 20 to evaluate Avastin and consider whether use in
breast cancer should be continued, expanded, or halted. The shares fell the most
in more than a year.
Roche, Europe’s largest drugmaker, won FDA approval of Avastin for breast cancer
in 2008 under an accelerated review that required the company to complete trials
proving the treatment, with $5.97 billion in sales last year, extends survival
or enhances quality of life. Withdrawal of approval may trim as much as $1
billion from annual sales by 2015, said Jack Scannell, an analyst with Sanford
C. Bernstein & Co. in London.
“My gut feeling would be that it doesn’t look good for Avastin,” said Nick
Turner, an analyst at Mirabaud Securities in London, in a telephone interview
today. “The real worry here may be that the adverse events associated with
Avastin are overriding any anti-cancer effect.”
Roche, based in Basel, Switzerland, fell 6.3 Swiss francs, or 4.2 percent, to
144.5 francs at the 5:30 p.m. close in Zurich, the most since April 22, 2009.
The stock has lost 18 percent this year.
Avastin is the first medicine to fight cancer by blocking the growth of blood
vessels that feed tumors, a process called angiogenesis. It targets a chemical
signal known as vascular endothelial growth factor, or VEGF. Avastin was
developed by Roche’s San Francisco-based Genentech unit, fully acquired by the
European drugmaker last year for $46.8 billion.
Breast cancer is the most common malignancy in females and strikes about 1
million women a year globally, according to the Geneva-based World Health
Organization. Avastin is approved for about three quarters of women whose breast
cancer has been recently diagnosed as having spread to other organs. It doesn’t
include women who have a mutation to the HER2 protein, a known risk factor.
Patients with HER2 mutations are eligible for another Roche drug, Herceptin.
The FDA clearance of Avastin for breast cancer overruled an advisory panel that
concluded the benefit of slowing the spread of tumors wasn’t worth the risk of
side effects including high blood pressure and death. The drug, also approved
for brain, lung and colon tumors, costs about $50,000 a year.
Approval was based on a clinical trial, called E2100, which showed Avastin
slowed the spread of breast cancer by an additional 5.5 months when paired with
paclitaxel chemotherapy, compared with the other drug alone, the FDA said today.
One trial completed since then, called Avado, showed that a high dose of Avastin
paired with docetaxel chemotherapy extended the time patients lived without
their disease worsening by 0.9 months, compared with treatment with chemotherapy
alone, the FDA report said. A lower dose of Avastin gave patients 0.8 months.
A second trial finished after approval, called Ribbon-1, found that Avastin
combined with taxane or anthracycline-based chemotherapies stalled tumor growth
by 1.2 months, compared to treatment with chemotherapy alone, the report said.
Patients who got Avastin combined with Xeloda lived 2.9 months longer without
their disease progressing, compared to chemotherapy alone.
“What we have learned through these trials is that there is a consistent
magnitude of benefit,” said Philippe Bishop, Roche’s vice president of clinical
development for Avastin, in a telephone interview yesterday. “There was no
significant increase in overall survival, but what is important in our
understanding is that there was also no added detriment.”
Drugs that win conditional clearance through the FDA’s accelerated-approval
program can later be pulled from the market if subsequent data fails to show
that a treatment increases long-term survival or slows progression of the
disease while improving quality of life.