Breast cancer indication should be removed from the Avastin (bevacizumab) label because it hasn’t been demonstrated to be safe and effective for that use, the FDA (Food and Drug Administration) is recommending. According to four clinical studies, Avastin does not prolong the life of breast cancer patients, neither does it slow down the progression of the disease, the FDA added.

The Agency says the significant risks to patients, including hypertension, bleeding and hemorrhage, the development of holes (perforations) in the body, heart attack, and heart failure, far outweigh any benefits.

An FDA Panel of consisting mainly of oncologists voted 12 to 1 in favor of removing the breast cancer indication from the label of Avastin.

Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said:

    “After careful review of the clinical data, we are recommending that the breast cancer indication for Avastin be removed based on evidence from four independent studies,. Subsequent studies failed to confirm the benefit observed in the original trial.

    None of the studies demonstrated that patients receiving Avastin lived longer, and patients receiving Avastin experienced a significant increase in serious side effects. The limited effects of Avastin combined with the significant risks led us to this difficult decision. The results of these studies are disappointing. We encourage the company to conduct additional research to identify if there may be select groups of patients who might benefit from this drug.”

This is the first step in the process of removing the breast cancer indication from the Avastin label, the FDA announced. This announcement has no bearing on Avastin’s approval for lung, brain, kidney and colon cancers. Neither does today’s action have any immediate impact on the medication’s use in breast cancer treatment.

Cancer specialists who are presently using Avastin on their metastatic breast cancer patients “should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.”

Avastin’s manufacturer, Genentech, has been informed by the FDA about its proposal to remove marketing approval of the medication for breast cancer. As the company has not voluntarily agreed to remove the breast cancer indication, the FDA has issued a Notice of Opportunity for a Hearing, allowing Genentech to request a public hearing if it so wishes within 15 days, in order to contest the FDA’s intention.

The hearing option will be waived if the company does not make a request within 15 days, and proceedings to remove the breast cancer indication will start.

Under the FDA’s accelerated approval program, Avastin alongside chemotherapy (paclitaxel) was approved in February 2008.

After approval, Genentech carried out further clinical trials and submitted their findings to the FDA. The trials showed a slight effect on progression-free survival. There was no evidence of any improvement in overall survival or clinical benefits which might outweigh the risks. The slight rise in progression-free survival was short-lived.

Avastin has been linked to other serious adverse events, such as:

  • Stroke
  • Wound healing complications
  • Organ damage or failure
  • The development of a neurological condition called reversible posterior leukoencephalopathy syndrome (RPLS), characterized by high blood pressure, headaches, confusion, seizures, and vision loss from swelling of the brain.

In a communiqué today, Genentech wrote that:

    “In the European Union, Avastin (has been) confirmed as a valuable treatment option in combination with Paclitaxel”

The company says the European Medicines Agency (EMA) has confirmed that Avastin plus palcitaxel has been convincingly shown to enable women with breast cancer to live longer without their disease getting worse (progression-free survival). It quotes EMA as saying that “the benefits of this combination outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer.” Source: FDA

Written by Christian Nordqvist