ODAC recommends Genentech sBLA

The FDA's Oncologic Drugs Advisory Committee voted 16-0 to recommend approval of a DNA sBLA that would allow physicians to use PathVysion, a fluorescence in-situ hybridization (FISH) assay from Vysis (VYSI), in selecting patients for therapy with DNA's Herceptin trastuzumab antibody to treat metastatic breast cancer. The vote came after market close, and DNA was up $1.09 to $58 on Wednesday. Trading of VYSI, which is being acquired by Abbott (ABT), was halted. ...