Shots:

• The approval is based on P-III FeDeriCa study evaluating the pharmacokinetics- efficacy- and safety of Phesgo + CT vs Perjeta + Herceptin (IV) + CT in 500 patients with HER2-positive early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery)
• Result of FeDeriCa Study: The GMR for the 1EPs (1.22) with the lower limit (90%) CI of the GMR (1.14≥0.80). 2EPs of non-inferior levels of Herceptin was also met with blood conc. GMR (1.33) with the lower limit (90%)
• Phesgo combines the same mAb as Perjeta and Herceptin with Halozyme Therapeutics Enhanze drug delivery technology in a novel formulation for SC use

 ­ Ref: Roche  | Image: Roche