FDA backs Roche's personalized breast cancer therapy Perjeta

The US Food and Drug Administration on Friday approved Swiss drug major Roche (ROG: SIX) subsidiary Genentech’s Perjeta (pertuzumab). Perjeta is cleared for marketing in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Analysts polled by Thomson Reuters have on average forecast annual pertuzumab sales of $608 million by 2016 - though some say sales could eventually climb beyond $1 billion. Herceptin alone generated global sales of $5.9 billion in 2011.

This approval is based on data from a Phase III study which showed that people with previously untreated HER2-positive mBC who received the combination of Perjeta, Herceptin and docetaxel chemotherapy lived a median of 6.1 months longer without their cancer getting worse (progression-free survival) compared to Herceptin plus docetaxel chemotherapy (median PFS 18.5 versus 12.4 months).