Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it has obtained regulatory approval today from the Ministry of Health, Labour and Welfare (MHLW) for Phesgo® combination for Subcutaneous Injection MA, IN [generic name: pertuzumab (genetical recombination), trastuzumab (genetical recombination) and vorhyaluronidase alfa (genetical recombination) ] (hereafter, Phesgo), antineoplastic agent / anti-HER2 humanized monoclonal antibody for the treatment of “HER2-positive breast cancer” and “Advanced or recurrent HER2-positive colorectal cancer that has progressed following cancer chemotherapy and is not amenable to curative resection.”

Phesgo is indicated 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...the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence...Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer...

PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for...Use in combination with chemotherapy as...neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer...adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence...Use in combination with docetaxel for treatment of patients with HER2­ positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Preoperative/adjuvant therapy for HER2-positive disease and systemic therapy for HER2-positive recurrent or stage IV (M1) disease: Footnote added: Pertuzumab, trastuzumab and hyaluronidase-zzxf injection for subcutaneous use may be substituted anywhere that the combination of intravenous pertuzumab and intravenous trastuzumab are given as a part of systemic therapy.

Roche...today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer....The recommendation from the CHMP is based on results from the pivotal phase III FeDeriCa study...

Pts with centrally confirmed HER2-positive invasive breast cancer...were randomized 1:1 to receive 8 cycles of CT in the neoadjuvant setting with H IV (loading dose 8 mg/kg, maintenance 6 mg/kg) + P IV (loading dose 840 mg, maintenance 420 mg) (Arm A) or CT per Arm A + PH FDC (loading dose 1200 mg P SC/600 mg H SC, maintenance 600 mg each; Arm B) administered q3w during cycles 5-8. CT was investigator’s choice of either 4 cycles of dose-dense doxorubicin + cyclophosphamide q2w → 4 cycles of weekly paclitaxel (total: 12 weeks), or 4 cycles of doxorubicin + cyclophosphamide q3w → 4 cycles of docetaxel q3w....SC PH FDC demonstrated noninferior pre-dose cycle 8 P + H Ctrough to that of P IV + H IV, with comparable efficacy and safety. PH FDC offers a faster and simpler method of P + H administration for HER2-positive breast cancer.

...HER2-positive breast cancer confirmed by a central laboratory prior to study enrollment. HER2-positive status will be determined based on pretreatment breast biopsy material...

PH FDC SC was well tolerated, with safety consistent with that of PH IV (except injection-site reactions) and no grade ≥3 anaphylaxis/hypersensitivity or new safety signals in the continuation period. Efficacy data are immature but show high IDFS and OS rates at 3 years.

PH FDC SC significantly saved Pts and HCP times and reduced use of healthcare resources….Together with previous findings showing comparable efficacy and safety profiles and Pts preference of PH FDC SC versus P-IV+H-IV in (neo)adjuvant settings, these results encourage the use of PH FDC SC for dual blockade treatments.