Two Biotech Drugs Approved for New Indications

On February 22, 2008, the US FDA approved two biotech drugs, Avastin (bevacizumab) and HUMIRA (Adalimumab), for additional indications. Avastin, made by Genentech, Inc. (South San Francisco, CA), was approved, in combination with paclitaxel chemotherapy, for advanced breast cancer. HUMIRA, made by Abbott (Abbott Park, IL) was approved as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis. 

Avastin is now approved for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer. Its approval is based on a Phase 3 study that showed that Avastin, in combination with paclitaxel chemotherapy, resulted in a 52% reduction in the risk of disease progression or death compared to those treated with paclitaxel alone, and a doubling in progression-free survival. Avastin, in combination with intravenous 5-fluorouracil-based chemotherapy, was previously approved for first- or second-line treatment of patients with metastatic colorectal cancer in 2001 and 2006, and also in combination with carboplatin and paclitaxel for the initial systemic treatment of patients with metastatic, non-squamous, non-small cell lung cancer in 2006.

Abbott has received FDA approval for HUMIRA’s use to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients four years of age and older. The approval is based on safety and efficacy results from a clinical study of JIA patients four to 17 years of age. HUMIRA is the first biologic treatment to receive FDA approval for this condition since 1999, and the first to be administered by injection in these patients once every two weeks. JIA is the sixth disease indication for which HUMIRA has received approval since 2002.

Genentech release

Abbott release