Genentech/Roche's Avastin gets unexpected OK for breast cancer in USA

In what was something of a surprise, the US Food and Drug Administration granted accelerated approval for US biotechnology major Genentech and majority parent Swiss drug major Roche's Avastin (bevacizumab), in combination with paclitaxel chemotherapy, for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer.

The move is unusual, because the FDA nearly always follows the recommendations of its advisory panels and, in this case, last year its Oncologic Drugs Advisory Committee voted five to four against approving the anticancer agent , arguing that its benefits did not outweigh the risks of toxicity (Marketletter December 10, 2007).The good news, which came late on February 22, sent Genentech's share up 7.8% to $77.20 in after hours trading. Roche's share price also saw a positive impact on the next trading day in Zurich, February 25, when it rose 4% to 204 Swiss francs, with analysts at Dresdner Kleinwort expecting 2008 incremental sales of some $600.0 million rising to $1.5 billion by 2012 from the added indication in the USA.