Thursday, May 24, 2012

Chugai files NDA for Pertuzumab to MHLW in Japan

Chugai has today filled an NDA for approval  of Pertuzumab to MHLW in Japan for use in combination with Trastuzumab (Herceptin) in first line HER2 postive breast cancer.

The application is based on the Phase 3 study CLEOPATRA. In the study  patients who received pertuzumab in combination with trastuzumab and docetaxel experienced a 38 percent reduction in the risk of their disease worsening or death (progression free survival; PFS) (hazard ratio=0.62; p<0.0001). The median PFS improved by 6.1 months from 12.4 months of trastuzumab and docetaxel to 18.5 months of pertuzumab, trastuzumab and docetaxel.

There is a growing incidence of breast cancer every year in Japan.