Shots:

• The BLA is based on P-III FeDeriCa study assessing FDC of Perjeta + Herceptin (SC) + CT vs Perjeta + Herceptin (IV) + CT in 500 patients with HER2-positive eBC who are being treated in the neoadjuvant & adjuvant settings
• The P-III FeDeriCa study resulted in meeting its 1EPs & 2EPs i.e. non-inferior levels of Perjeta & Herceptin in the blood during a given dosing interval (Ctrough) respectively- demonstrated comparable total pCR- no new signals were identified including no differences in cardiac toxicity
• The FDC combination is a new SC formulation that combines Perjeta and Herceptin with Halozyme’s Enhanze drug delivery technology which is based on (rHuPH20) with its expected FDA’s approval by Oct 18- 2020

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