Genentech submits sBLAs to the FDA for Avastin

Genentech, Inc.,Nov 17 2009

Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Avastin^® (bevacizumab) for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment). One sBLA is based on the Phase III study AVADO that investigated Avastin in combination with docetaxel chemotherapy. The other is based on the Phase III study RIBBON 1 that investigated Avastin in combination with a taxane, anthracycline-based or capecitabine chemotherapy. Both studies met their primary endpoints of improving the time women lived without the disease worsening (progression-free survival or PFS).

Avastin is currently approved in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer. This approval was based on results of the Phase III E2100 study and granted under the FDA’s accelerated approval program, which allows provisional approval of medicines for cancer or other life-threatening diseases. Currently, the effectiveness of Avastin in metastatic breast cancer is based on an improvement in PFS. Avastin is not indicated for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease. No data are available that demonstrate an improvement in disease-related symptoms or increased survival with Avastin in breast cancer.

"We look forward to working with the FDA to evaluate the data from more than 2,600 women with advanced breast cancer who participated in these studies that showed Avastin in combination with various chemotherapies helped them live longer without the disease worsening,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer.

AVADO and RIBBON 1 demonstrated that Avastin plus commonly used chemotherapies (taxane, anthracycline-based or capecitabine chemotherapy) increased the time women lived without the disease growing or spreading, compared to the chemotherapies alone. In these studies, adverse events were consistent with those previously reported for Avastin and no new Avastin safety signals were observed. Data from AVADO and RIBBON 1 are being submitted as part of Genentech’s effort to convert the accelerated approval to a full approval.