Genentech granted FDA hearing on Avastin for metastatic breast cancer

GenentechFeb 25 2011

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," 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."

The FDA's letter notifying Genentech the hearing has been granted is available on http://www.regulations.gov under Docket No. FDA-2010-N-0621. On January 18, 2011, Genentech submitted its response to the FDA's Notice of Opportunity for a Hearing ("NOOH") on the Agency's proposal to withdraw approval of the mBC indication. The response set forth the Avastin data, analyses and information that Genentech will review with the FDA at the hearing. The company's response and supporting documentation are available on Genentech's website at http://www.gene.com/gene/news/news-events/avastin/ or on http://www.regulations.gov under Docket No. FDA-2010-N-0621.

The effectiveness of Avastin in HER2-negative mBC is based on an improvement in progression-free survival in the E2100 study. There are no available data showing that Avastin improves disease-related symptoms or survival in HER2-negative mBC. Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease.

Doctors with questions about the use of Avastin for mBC can call Genentech's Medical Communications group at (800) 821-8590. Patients with questions or concerns about insurance coverage can call Genentech's Access Solutions Group at (866) 4 ACCESS.