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 […]Read More
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 […]Read More
Shots: The P-III FeDeriCa study involves assessing of SC inj. of Perjeta + Herceptin + CT vs IV infusion of Perjeta + Herceptin + CT in 500 patients with HER2+ who are being treated in the neoadjuvant and adjuvant setting The P-III FeDeriCa study results: met its 1EP & 2EPs i.e, minimum levels of Perjeta […]Read More
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