The date for the hearing is a few months off and until that time the drug is still approved as a first line treatment of the HER2 Negative mBC (breast cancer). Genentech filed the request for a formal hearing and the opportunity to present additional documentation to support continued use for treating women with metastatic breast cancer. BD
Roche (Genentech) Requests Hearing From the FDA Regarding Avastin for Breast Cancer-Did These Numbers Come From the United Health Care Oncology Study-Subsidiary Watch
SOUTH SAN FRANCISCO, Calif.--(EON: Enhanced Online News)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has granted a hearing to allow the company the opportunity to present its views on why Avastin® (bevacizumab) should remain FDA-approved for metastatic breast cancer (mBC). The FDA has scheduled the hearing for June 28 to 29, 2011. Currently, and until the conclusion of the proceedings with the FDA, Avastin remains approved for use in combination with paclitaxel for the first-line treatment of HER2-negative mBC in the United States.
“We appreciate the opportunity to continue our discussion with the FDA during a public hearing about the use of Avastin in metastatic breast cancer”
“We appreciate the opportunity to continue our discussion with the FDA during a public hearing about the use of Avastin in metastatic breast cancer,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We believe Avastin is an important option for women with this disease and should remain an FDA-approved choice.”
Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease.