Shots:

• The approval is based on three P-III study (HannaH- SafeHER- PrefHER) results assessing Herceptin Hylecta (SC) + CT vs Herceptin (IV) + CT in neoadjuvant and adjuvant patients with HER2-positive early breast cancer
• P-III HannaH- SafeHER- PrefHER study: pCR (absence of invasive cancer cells in breast) (45.4% vs 40.7%); mean level of trastuzumab (78.7mcg/ml vs 57mcg/ml); no new safety signals- tolerable
• Herceptin Hylecta (trastuzumab and hyaluronidase-oysk- SC) based on Halozyme’s Enhanze drug delivery technology targeted for patients with HER2-positive early breast cancer

Ref: Roche | Image: Roche