ROCHE – Perjeta -First approved therapy in preoperative, early stage, HER2 positive breast cancer; Roche strengthening its breast cancer franchise

Date: 2015-07

FDA granted accelerated approval to Roche’s Perjeta for the treatment of high risk, neoadjuvant breast cancer. This is the first drug to be approved for this indication and the approval was based on pathological complete response (pCR) data from PhII NEOSPHERE (Neoadjuvant Study of Pertuzumab and Herceptin in an Early Regimen Evaluation) study. FDA guidelines on pCR in neoadjuvant treatment of high risk early stage breast cancer for accelerated approval have been released in May 2012. The course of treatment will vary between 9 and 18 weeks and the cost would range from $27K and $49K depending on the duration of course. We expect, this bundling price will allow Roche to sustain its revenue from Biosimilar threat of Herceptin going forward.

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