PhesgoRoche Products Ltd
Roche Products Ltd
Solution for injection
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12 November 2021
London MI Service
PhesgoEarly and metastatic HER2-positive breast cancer - SC co-formulation
Development and Regulatory status
Jan 21Roche intends to make stock available in the UK by mid-January. Basic NHS cost (excluding VAT) is £3,617 per 600 mg/600 mg in 10ml vial and £6,012 per 1200 mg/600 mg in 15ml vial. Roche is currently in discussions with NHS England and hopes NHS funding will be in place soon .
Dec 20Approved in EU .
Nov 20Recommended for EU approval by CHMP - the full indication is "Early breast cancer (EBC); for use 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 (see section 5.1); the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1). Also in Metastatic breast cancer (MBC); in combination with 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." It should be prescribed by physicians experienced in the administration of anti-cancer agents .
Oct 20Phesgo has been launched in the US .
Jun 20Approved in US for treatment of adult patients with early HER2-positive breast cancer .
Feb 20Also pre-registration in US .
Feb 20Filed in EU via centralised procedure .
Oct 19Plans for filing in 2020 unchanged .
Jul 18EU & US filings planned for 2020 .
Fixed-dose combination of pertuzumab (HER dimerisation inhibitor) plus trastuzumab (anti-HER2 monoclonal antibody).
In 2014, there were approximately 46,500 new diagnoses of breast cancer in England. It is estimated that approximately 15-25% of women with breast cancer will have HER2-positive tumours .
Early and metastatic HER2-positive breast cancer - SC co-formulation
Trial or other data
Dec 20PIII FeDeriCa RCT (n=500) reports subcutaneous fixed-dose combination of pertuzumab+trastuzumab provides non-inferior cycle 7 pertuzumab serum C trough concentrations to intravenous pertuzumab+trastuzumab in the neoadjuvant setting with comparable total pathological complete response rates .
Dec 19Roche announces results from second interim OS analysis of PIII APHINITY study. In study (n=4805), at median follow-up of ~ 74 months, addition of pertuzumab to trastuzumab and chemotherapy reduced risk of breast cancer recurrence or death by 24% vs. addition of placebo. At 6 years, 90.6% have not had breast cancer return, vs. 87.8% in the placebo arm .
Sep 19Roche announce PIII FeDeriCa study meets primary endpoint .
Jan 19Recruitment complete in FeDeriCa study .
Jun 18First patient enrolled in global PIII FeDeriCa study comparing a fixed-dose combination of pertuzumab and trastumab plus chemotherapy with IV pertuzumab plus IV trastuzumab plus chemotherapy as adjuvant and neoadjuvant therapy of 500 patients with early HER2-positive breast cancer (NCT03493854). Primary outcome is trough serum concentration of pertuzumab during cycle 7. Patients will be recruited in countries including the US & EU (plus UK). Collection of primary outcome data due to complete Mar 20 [2,3].