Susan G. Komen for the Cure® encouraged continued coverage for breast cancer patients benefitting from the cancer drug Avastin and the continued development of breast cancer treatments, following a U.S. Food and Drug Administration (FDA) decision to begin the process of removing approval of Avastin as a treatment for metastatic breast cancer.
“As a patient advocate organization, we call 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”
The FDA’s decision gives drug manufacturer Genentech/Roche 15 days to file an appeal for a public hearing and a process of review that could take several months. The FDA emphasized that Avastin is not being removed immediately from the market and today’s action would not have an immediate impact on treatment for breast cancer.
The FDA cited studies that indicate Avastin did not affect overall survival of metastatic breast cancer patients and had significant side effects for many.
Komen for the Cure’s president, Elizabeth Thompson, said that the organization is concerned about the potential impact on women who are benefitting from Avastin if the FDA ultimately removes its approval for the drug for breast cancer treatment.
“We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it, that their insurers will continue to pay for it and that the drug’s manufacturer, Genentech/Roche, continues making the drug available to women through its patient support programs and considers an expanded access program,” Thompson said.
“We are also urging Genentech/Roche to continue research on a biomarker for Avastin to determine which women will benefit from the drug. We are supportive of the drug development process and hope that manufacturers will continue to develop medications for the treatment of metastatic breast cancer. We will only succeed in finding new treatments for cancer by bringing new drugs to the clinic,” she said.
“As a patient advocate organization, we call 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,” Thompson concluded.
Source: Susan G. Komen for the Cure®