A panel of cancer experts said Tuesday that the government should remove its endorsement of Roche's drug Avastin for breast cancer after follow-up studies failed to show benefits for patients.
A Food and Drug Administration (FDA) panel of experts voted 12-1 in favor of removing the drug's approval for use against breast cancer alongside chemotherapy
The FDA is not required to follow the advice of its panel, though it often does, also the panel's recommendation does not affect the use of Avastin to treat other cancers, including colon and lung cancers.
Avastin does not help patients
The recommendation came after trials showed that taking Avastin did not benefit patients with metastatic breast cancer and "that there were, indeed, more side effects when patients took Avastin," FDA spokeswoman Karen Riley said.
Avastin had been approved for treatment of advanced breast cancer under the FDA's accelerated approval program, which allows provisional approval of medicines for cancer or other life-threatening diseases.
The final decision on whether to remove the breast cancer indication from the Avastin label will be taken by the FDA and will only affect the use of Avastin to treat breast cancer patients in the United States.
"The recommendation does not impact the use of Avastin for advanced breast cancer in other countries," Genentech, the Roche-owned pharmaceutical company that makes Avastin, said in a statement.
In the same time, Riley was unable to say when the FDA will make its decision on whether or not to remove the breast cancer indication from Avastin's U.S. label. Also, Genentech said the decision was expected by mid-September.
Swiss studies made a difference
As a condition of approval, Roche was required to conduct follow-up studies to demonstrate the benefits of adding Avastin to conventional chemotherapy.
But two follow-up studies recently submitted by the Swiss drugmaker did not show the same degree of delay in cancer progression as earlier studies.
Additionally, patients taking Avastin did not show a significant improvement in lifespan, the gold standard of cancer treatment effectiveness, however it delayed cancer growth by up to three months.
Also, Roche said the company stands by its data showing Avastin helps patients with advanced breast cancer. "Avastin should be an option for patients with this incurable disease," a company statement said.
Earlier this month, Britain's health cost watchdog said it was rejecting Avastin for breast cancer due to "uncertain evidence."
Withdrawal of the breast cancer approval would curb, but not eliminate, sales for that use, Sanford Bernstein analyst Tim Anderson said.
"Even with savage and pessimistic assumptions, perhaps $1 billion of 2015 sales could go," or about a 5 percent hit to earnings per share, Anderson said in a research note.
Breast cancer treatment accounts for about $1 billion of Avastin's more than $6 billion in annual sales, analysts said. The product is Roche's top-selling drug, accounting for 13 percent of sales in 2009.
The drug's wholesale cost is about $8,000 per month for advanced breast cancer. Roche limits the annual cost for any FDA-approved use to about $57,000.
The FDA is not allowed to consider cost when deciding on drug approvals.
Also, the FDA in 2008 approved Avastin for breast cancer patients based on a trial showing it extended the amount of time until the disease worsened by more than five months. The decision was considered controversial by some cancer doctors because the drug had not been shown to extend patients' lives.