The Food and Drug Administration said today it is beginning the process to rescind Avastin’s accelerated approval in breast tumors. The medicine, also cleared for lung, brain and colon cancer, had global sales of 6.22 billion Swiss francs last year, or $5.75 billion based on the average 2009 exchange rate.
Avastin was granted conditional marketing approval for breast cancer in 2008 based on preliminary data. An FDA advisory panel recommended revoking that approval in July because follow-up studies found the medicine increased side effects and didn’t prolong survival when paired with chemotherapies. The agency’s decision goes further than European regulators, who announced today they would limit the drug’s use in breast cancer.
“The limited effects of Avastin combined with the significant risks led us to this difficult decision,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “We encourage the company to conduct additional research to identify if there may be select groups of patients who might benefit from this drug.”
Roche said it will request a hearing on the decision; the FDA will take at least through January to review the appeal. A hearing, if granted, would be the first of its kind, the agency said. The Basel, Switzerland-based company fell 1.2 francs, or 0.9 percent, to 140 francs at 5:50 p.m. in Zurich trading.
“It’s uncharted territory,” said Stefan Frings, Roche’s Avastin franchise director, in a telephone interview. “There’s no company ever that has done this in the context of an accelerated approval.”
The FDA urged doctors to review patients currently on the drug. If approval is revoked, U.S. doctors still would be able to prescribe Avastin for breast cancer as an “off-label” use, though Roche won’t be allowed to market it this way. Reimbursement from insurers and government health programs may also be challenging without regulatory approval. Treatment costs about $50,000 annually.
‘Not to Zero’
“I wouldn’t be surprised if this trims European use as well, but not to zero,” Scannell said today in a telephone interview.
Avastin was initially cleared for use with paclitaxel chemotherapy as a first-line treatment for women with breast cancer that has spread to other organs and doesn’t show the HER-2 protein linked to aggressive tumor growth. Roche had asked the FDA to convert the conditional approval to full clearance and allow the medicine to be used with other chemotherapy agents.
“I’m stunned by this decision,” said Edith Perez, deputy director of the Mayo Clinic Comprehensive Cancer Center in Jacksonville, Florida, in a telephone interview today. “I’m saddened for patients that they may not get this option.”
Data from four studies in breast cancer, including the one used to support the initial approval, no longer support a positive ratio of benefits and risks, Woodcock told reporters today on a conference call. The agency didn’t consider cost in its assessment, she said.
Medicare, the U.S. health plan for the elderly and disabled, won’t change its reimbursement policies for Avastin until the FDA review is resolved, Woodcock said.
Introduced in 2004, Avastin was the first medicine to fight cancer by blocking the growth of blood vessels that feed tumors, a process called angiogenesis.
Roche’s efforts to expand Avastin’s use have encountered setbacks this year. Study results showed the drug failed to prolong the lives of patients with prostate, stomach and early colorectal cancer, while Avastin also failed a clinical trial of women with early stage breast malignancies.
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.
Pfizer Inc. (PFE)’s leukemia treatment Mylotarg became in June 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 shouldn’t be used with Sanofi-Aventis SA’s Taxotere drug as a treatment for metastatic breast cancer, the European Medicines Agency, the drug regulator for the 27 countries of the European Union, said today in a statement. Avastin can still be used with paclitaxel, the agency said.
The agency rejected Roche’s application to expand use with its Xeloda drug.