Genentech, Inc. announced that the company submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Avastin(R) (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.

Genentech Inc. announced two-year results from a Phase III study, which showed that people with rheumatoid arthritis (RA) who received either a 4 mg/kg or 8 mg/kg dose of ACTEMRA(R) (tocilizumab), in combination with methotrexate, had no progression of joint damage, (75 and 83%, respectively, as assessed by radiograph) compared with people who received methotrexate alone (66%). The overall safety profile of ACTEMRA was consistent across all global clinical studies. The study, known as LITHE, will be featured as an oral presentation during the American College of Rheumatology (ACR) Annual Scientific Meeting along with results from two additional studies evaluating the long-term use of ACTEMRA in people with RA. The LITHE study also showed that people who received either dose of ACTEMRA plus methotrexate showed significant improvement in physical function, compared with people who received methotrexate plus placebo, as measured by the mean area under the curve (AUC) of the Health Assessment Questionnaire Disability Index (HAQ-DI)i change from baseline. In addition, 65% of people who received ACTEMRA (8 mg/kg) plus methotrexate for two years had their disease go into remission compared with 48% of people treated for just one year. In this study, remission was defined by achieving a disease activity score (called DAS28) of less than 2.6ii. DAS28 is a commonly used tool that assesses a variety of measures, including swollen and tender joints at multiple time points.

Genentech Inc. a wholly-owned member of the Roche Group and Biogen Idec Inc. announced that the companies received a Complete Response from the U.S. Food and Drug Administration (FDA) for a supplemental Biologics License Application (sBLA) for Rituxan(R) (rituximab) plus methotrexate (MTX) in patients with moderately-to-severely active rheumatoid arthritis (RA) who no longer respond to treatment with a disease modifying antirheumatic drug (DMARD), including MTX. The FDA has indicated that they do not believe an approval for Rituxan (in people with RA who have not previously received MTX or those who were MTX inadequate responders) can be supported at this time due to the rare risk of progessive multifocal leukeoencephalopathy (PML) in light of the number of effective RA treatments currently available to patients in earlier stages of the disease. PML is a usually fatal brain disease caused by the reactivation of a common virus called the JC virus. Although the incidence of PML in RA patients treated with Rituxan is rare (as of, three reports out of approximately 100,000 patients), there are no known reliable PML treatments. The FDA approved an additional sBLA submission to include updated safety and efficacy data in the label that provides guidance on how later-stage patients, those who have inadequately responded to tumor necrosis factor (TNF)-antagonist therapies, can be retreated with Rituxan.