PHESGO (pertuzumab, trastuzumab)

Key points

Favourable opinion for reimbursement in combination with docetaxel only in the treatment of 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.

Unfavourable opinion for reimbursement in the two indications in combination with chemotherapy in:

• the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence
• the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.

What therapeutic improvement?

No clinical added value compared to the free combination of PERJETA (pertuzumab) and HERCEPTIN (trastuzumab) in the treatment of 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

In the other indications: not applicable.

 Role in the care pathway?

Early breast cancer

The treatment of early breast cancer may be based on surgery, radiotherapy, chemotherapy (neoadjuvant and/or adjuvant) and endocrine therapy, depending on the tumour type and grade, axillary lymph node involvement and the existence of hormone receptors.

In both the neoadjuvant and adjuvant situation, the most widely used protocol for HER2-positive early breast cancer is based on anthracycline-based chemotherapy followed by taxane-based chemotherapy combined with targeted therapy with trastuzumab.

It is highlighted that the Committee considered that the clinical benefit of PERJETA (pertuzumab), in combination with trastuzumab and chemotherapy, was insufficient in the neoadjuvant and adjuvant treatment of early breast cancer. Consequently, PERJETA (pertuzumab) has no role in the care pathway for these two indications.

Role of the medicinal product in the care pathway

Considering the absence of a role in the care pathway for the free active substance PERJETA (pertuzumab) in its two early breast cancer indications, the Committee considers that PHESGO (pertuzumab/trastuzumab) has no role in the care pathway, in combination with chemotherapy, in the neoadjuvant or adjuvant treatment of early breast cancer.

Metastatic breast cancer

In HER2-positive metastatic breast cancer, it is essential to maintain an anti-HER2 action, irrespective of the treatment line. In the first-line treatment of metastatic breast cancer, in the event of over-expression of HER2, treatment is based on taxane-based chemotherapy in combination with trastuzumab (HERCEPTIN) and pertuzumab (PERJETA)

Role of the medicinal product in the care pathway

The proprietary medicinal product PHESGO (pertuzumab/trastuzumab), administered subcutaneously, is an alternative to the free combination of the two active substances already available individually: PERJETA (pertuzumab) and HERCEPTIN (trastuzumab), in the first-line treatment of HER2-positive metastatic breast cancer.