Shots:

• The approval is based on P-III FeDeriCa study which involves assessing of Phesgo (SC) + CT vs Perjeta (pertuzumab- IV) & Herceptin (trastuzumab- IV) + CT in 500 patients with HER2+ve early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings evaluated PK- efficacy- and safety
• The study met its 1EPs showing non-inferior levels of Phesgo (SC) vs Perjeta (IV) in the blood plus no cardiac toxicity was demonstrated also the safety profile was comparable including no new safety signals. Additionally- in the P-II PHranceSCa study- 85% (136/160) patients preferred SC vs IV administration involving less time in the clinic with more comfort
• Phesgo is an (FD- SC) formulation which involves a combination of pertuzumab + trastuzumab developed using Halozyme Therapeutics’ Enhanze drug delivery technology and administered within 8 mins for initial dosing and 5 mins for maintenance dosing

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Ref: Roche | Image: Roche