European Medicines Agency Recommends a New Indication for Pertuzumab

Concerns neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence

On 25 June 2015, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product pertuzumab (Perjeta).

The marketing authorisation holder for this medicinal product is Roche Registration Ltd.

The CHMP adopted a new indication as follows: Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally-advanced, inflammatory, or early-stage breast cancer at high risk of recurrence.

For information, the full indications for Perjeta will be as follows:

Metastatic Breast Cancer

Perjeta is 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.

Neoadjuvant Treatment of Breast Cancer

Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.