CHMP recommends approval of extension to indication for Perjeta + Herceptin to include early breast cancer.- Roche.

The CHMP recommends approval recommending a change to the terms of the marketing authorisation for Perjeta (pertuzumab), from Roche, in combination with trastuzumab and chemotherapy. The CHMP adopted an extension to the existing indication as follows: For early breast cancer. Perjeta is indicated for use in combination with trastuzumab and chemotherapy in: the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence, plus the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.

The drug is also indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.