Roche submits EU application for subcutaneous Herceptin

Roche (SIX:ROG; OTCQX:RHHBY) submitted a regulatory application to EMA for subcutaneous Herceptin trastuzumab to treat HER2-positive breast cancer. Roche said subcutaneous administration of Herceptin is less invasive and takes approximately five minutes instead of 30-90 minutes with the approved IV administration. The regulatory application is based on data from the Phase III HannaH trial presented Friday at the at the European Breast Cancer meeting in Vienna. Subcutaneous Herceptin produced a complete pathologic response rate, a co-primary endpoint, of 45.4% vs. 40.7% for IV Herceptin. Additionally, serum trastuzumab concentration, also a co-primary endpoint, measured just prior to surgery was 69 ug/mL for subcutaneous Herceptin vs. 51.8 ug/mL for IV Herceptin. Roche previously said subcutaneous Herceptin met the co-primary endpoints of comparable concentrations and comparable complete pathologic response rates vs. IV Herceptin (see BioCentury, Oct. 18, 2011). ...