Susan G. Komen for the Cure® and the Ovarian Cancer National Alliance (OCNA) today urged the U.S. Food and Drug Administration (FDA) to continue to allow the use of the drug bevacizumab, commonly known as Avastin, for metastatic breast cancer patients, noting that it is effective for some patients and warning of a chilling effect on new drug development if approval is withdrawn.
“We are particularly concerned about patients who are presently receiving bevacizumab and the message that this decision sends about drug development for women with advanced breast cancer.”
In a joint letter sent to the FDA and key Congressional lawmakers Thursday, Komen for the Cure and the OCNA wrote, "We are particularly concerned about patients who are presently receiving bevacizumab and the message that this decision sends about drug development for women with advanced breast cancer."
"We recognize the benefits of Avastin overall are modest for women with metastatic breast cancer," said Ambassador Nancy G. Brinker, Komen's founder and CEO, in the joint letter to the FDA. "However, we do know that for some women, Avastin offers a greater than modest benefit. We hope that this decision will not restrict access to Avastin to all patients."
In two studies that followed Avastin's accelerated FDA approval in 2008, researchers found the drug provided patients with metastatic disease (that is, breast cancer that has spread to other parts of the body) with an average of less than three additional months without their tumors growing while increasing the number of side effects. But many doctors report patients taking Avastin enjoy "better than modest results" according to the joint Komen-OCNA letter to the FDA.
According to Komen, the decision to use Avastin should be made between a woman and her doctor after a thoughtful conversation that carefully considers the drug's benefits and risks. Komen does not want to see access limited by Medicare and Medicaid.
While FDA approval is not required for a doctor to prescribe a drug, Komen and the OCNA are concerned the panel's decision could limit the so-called "off-label" use of Avastin for metastatic breast cancer if medical professionals are led to believe the drug is not effective for any women.
"Moving into the world of personalized medicine, cancer treatments will be more tailored to the characteristics of patients' individual tumors," the letter reads. "Yet, due to the current state of the science, we don't always know which patients will benefit most before a drug is made commercially available."
More research is needed to identify biomarkers (substances in the body whose detection indicates a particular disease) for doctors to use to more accurately predict which patients will benefit most.
If the FDA does withdraw its approval of Avastin for metastatic breast cancer, Komen and the OCNA are concerned about the potential damaging impact such a decision may have on future drug development.
"We hope that drug manufacturers will continue to develop medications for the treatment of metastatic breast cancer, and would not want this decision to mean that drug development for breast cancer comes to a crashing halt," the organizations' letter read.
Avastin is an "anti-angiogenesis" drug, which means it blocks the formation of blood vessels that feed cancer tumors. Restricted blood flow helps slow the growth and spread of cancer. The drug has been approved for colon, brain, certain types of lung and other cancers. The panel's recommendation does not affect the drug's approval for those concerns.
As the world's largest grassroots breast cancer organization, Komen is calling on all stakeholders — government, private industry, academia and the nonprofit community — to invest in the development of biomarkers and new drugs and to get the new technology and treatments to patients' bedsides as safely and as quickly as possible. Further, Komen hopes women who are currently being treated with Avastin for metastatic breast cancer continue to have access to the drug, and that third-party payers continue to cover it.
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