ODAC to discuss GSK's Tykerb in combination with Herceptin

FDA's Oncologic Drugs Advisory Committee will meet on July 24 to discuss an sNDA for Tykerb lapatinib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). GSK is seeking approval for Tykerb in combination with Herceptin trastuzumab to treat metastatic, HER2-positive breast cancer in patients who have received prior therapy with Herceptin. Tykerb is already approved in the U.S. for use in combination with an aromatase inhibitor or with capecitabine. Herceptin is marketed in the U.S. by the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) and by Roche elsewhere. ...