Genentech and majority stakeholder Roche have been boosted by data from a second late-stage trial of Avastin which may help the firm in its bid to get the blockbuster approved as a breast cancer treatment.
The company says that AVADO, a Roche-sponsored Phase III, placebo-controlled study evaluating Avastin (bevacizumab) in combination with docetaxel met its primary endpoint of prolonging progression-free survival in breast cancer patients who had not received prior chemotherapy. The 736-patient study investigated the addition of Avastin administered either at 15 mg/kg or 7.5 mg/kg every three weeks to docetaxel and both doses, in combination with chemotherapy, showed statistically significant improvement in the time patients lived without their disease advancing.
The data is particularly interesting as Genentech is looking to get the green light in the USA for Avastin, which is already approved colorectal and lung cancers, as a treatment for breast cancer in combination with paclitaxel, not docetaxel, the chemotherapy used on the AVADO trial. A Food and Drug Administration decision is expected later this month but Genentech received a setback in December when one of the agency’s advisory panels voted 5 to 4 against approval.
The FDA committee said the drug’s effectiveness in slowing the progression of breast cancer did not outweigh Avastin’s toxic side effects. However Genentech said that the results of the AVADO study provide confirmation of Avastin’s efficacy and safety in this patient population, albeit in combination with a different chemotherapy to the one on its supplemental Biologics License Application.
The company added that it has shared the AVADO data with the FDA “to assist the agency in assessing the risk and benefit of Avastin in this patient population,” and observers are speculating that the FDA may indeed plump for approval on February 23. A new indication would do US Avastin sales, which came in last year at around $2.7 billion, no harm at all.
