Roche Delayed on Proposed Expanded Use of Avastin

Roche Holding AG (ROG) said U.S. regulators, seeking more data, delayed its application to allow use of the Avastin cancer drug against breast tumors.

The Food and Drug Administration had been expected to decide today on the application. Instead, the FDA said it would take action by Dec. 17 on whether Avastin should gain approval for initial treatment of breast cancer that has spread, when combined with chemotherapies, the Genentech unit of Basel, Switzerland-based Roche said in a statement today. The drug already is being used in this way under a conditional approval.

The medicine, cleared for brain, lung and colon tumors, is the first to fight cancer by blocking the growth of blood vessels that feed tumors, a process called angiogenesis. Broadening its use for breast cancer may add 1 billion francs ($990 million) in annual sales, said Carri Duncan, an analyst at Macquarie Group in Zurich, before the announcement.

“We are pleased by the FDA’s decision to review additional information on Avastin and are committed to working closely with the agency during this extended review period,” Hal Barron, the company’s chief medical officer, said in the statement.

Avastin generated 1.73 billion Swiss francs in revenue during the second quarter. The medicine was developed by the company’s South San Francisco, California-Genentech unit, fully acquired by the European drugmaker last year for $46.8 billion.

Accelerated Approval

The FDA in 2008 granted conditional clearance through the agency’s accelerated-approval program for the drug’s use in breast cancer, alongside the chemotherapy paclitaxel.

In November 2009, the Swiss company asked the FDA to expand approval to allow the drug to be paired with the additional chemotherapies, including capecitabine, a Roche medicine sold under the brand name Xeloda.

In July, an advisory panel in July voted 12 to 1 in favor of rescinding the accelerated approval. Study data failed to convince the panel that Avastin had a “clinically meaningful” benefit over chemotherapy alone in keeping cancer at bay.

“The real issue for the FDA remains that the drug doesn’t show any improvement in overall survival for breast cancer, no matter how the data are interpreted,” Duncan said.

The FDA’s 2008 clearance 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 FDA usually follows panels’ advice, though it isn’t required to do so.

Conditional Clearance

Drugs that win conditional clearance 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.

Pfizer Inc. (PFE)’s leukemia treatment Mylotarg in June became the first drug with accelerated approval to come off the market after studies linked it to deaths from liver and lung complications and failed to prove it works. New York-based Pfizer, the world’s largest drugmaker, voluntarily halted sales of the drug, which won accelerated FDA approval 10 years ago based on preliminary data showing improved remission rates.

Avastin’s conditional clearance was based on a clinical trial, called E2100, which showed the drug stalled breast cancer by an additional 5.5 months on average when paired with paclitaxel, compared with chemotherapy alone, the FDA said in its report.

Study Results

A later trial, called Avado, showed a high dose of Avastin paired with docetaxel chemotherapy kept the disease at bay for 0.9 months, compared with treatment by chemotherapy alone, an FDA review said July 20. A lower Avastin dose gave patients an additional 0.8 months.

Another clinical study completed after approval, called Ribbon-1, found Avastin combined with taxane or anthracycline-based chemotherapies stalled tumor growth by 1.2 months, compared with treatment with chemotherapy alone, the agency said in its review. Patients who were treated with Avastin combined with Xeloda lived 2.9 months longer without their disease progressing, compared to those given chemotherapy by itself.

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.

To contact the reporter on this story: Dermot Doherty in Geneva at ddoherty9@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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