European health regulators are reviewing whether Roche Holding AG’s Avastin should continue to be used as a treatment for breast cancer that has spread.
A clinical trial that Roche says supports expanded use of the treatment in breast tumors was inconsistent with results from previous studies, particularly in terms of efficacy, the European Medicines Agency said today in a statement on its website.
The agency’s review, along with a U.S. regulatory study of Avastin’s effectiveness against breast malignancies, threaten sales of Roche’s best-selling medicine, which generated 6.2 billion Swiss francs ($6.3 billion) last year. Roche said it stands by Avastin and that the most recent study, dubbed Ribbon- 1, shows it helps breast-cancer patients.
“We believe that, based on the positive benefit-risk profile, the Ribbon-1 data support the label expansion,” Alexander Klauser, a spokesman at Roche, said in a telephone interview. “The current use of Avastin in its licensed indications, including metastatic breast cancer, is not affected by the review.”
Roche, based in Basel, Switzerland, fell 1.6 Swiss francs, or 1.2 percent, to 133.8 Swiss francs at 5:31 p.m. in Zurich trading.
The review raises the possibility that Roche will lose marketing permission in Europe for Avastin in breast cancer, though the medicine would likely still be prescribed by doctors against such malignancies, said Carri Duncan, an analyst at Macquarie Group in Zurich.
“It’s another reminder that pharma revenue will not be growing as it has historically, but analysts have already written this indication off and the impact will be more on sentiment,” she said.
Avastin is approved in the U.S. and Europe for use in the advanced stages of colorectal cancer, non-small cell lung cancer, kidney cancer and breast cancer. Roche submitted the study to the agency in support of an application to use Avastin in combination with anthracycline-based or Xeloda chemotherapy for breast tumors, the EMA said.
Roche won European approval in 2007 for Avastin paired with paclitaxel chemotherapy as an initial treatment for breast cancer that has spread. Health regulators expanded that use in 2009 to include combination with Sanofi-Aventis SA’s Taxotere. Those approvals were based on results from two separate studies, dubbed E2100 and Avado, Roche said.
The E2100 trial 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, according to the U.S. Food and Drug Administration. One trial completed since then, called Avado, showed that a high dose of Avastin paired with Taxotere extended the time patients lived without their disease worsening by 0.9 month, compared with chemotherapy alone, the FDA said in July.
The Ribbon-1 study found Avastin combined with taxane or anthracycline-based chemotherapies stalled tumor growth by 1.2 months, compared with treatment with chemotherapy alone, the FDA review found. Patients who were treated with Avastin combined with Xeloda lived 2.9 months longer without their disease progressing, compared with those given chemotherapy.
A decision on the application for expanded use of Avastin in breast cancer is expected later this year, Klauser said.
The FDA on Sept. 17 delayed Roche’s application to expand use of Avastin in breast cancer. In July, a U.S. advisory panel voted 12 to 1 in favor of rescinding the so-called accelerated approval. Study data failed to convince the panel that Avastin had a “clinically meaningful” benefit over chemotherapy alone in keeping cancer at bay.
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.
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