Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin) Receives the US FDA’s Approval for Early and Metastatic HER2-Positive Breast Cancer

Roche Reports Results of Tecentriq (atezolizumab) + Avastin (bevacizumab) in P-III IMbrave150 Study in Chinese Patients with Hepatocellular Carcinoma

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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