In USA, Roche wins priority review for adjuvant Perjeta-based regimen

Roche has been given priority review status for its bid to broaden the label for Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy.

The Swiss firm wants to extend the marketable uses of the combination therapy in the USA to include adjuvant treatment of HER2-positive early breast cancer.

The FDA is expected to make a decision on the application, which is supported by data from the Phase III APHINITY study, by 28 January 2018.

In the presurgical setting, the therapy is approved in 85 countries including in Europe and the USA.