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Subcutaneous pertuzumab + trastuzumab non-inferior to the IV combination

SABCS 2019
Phase 3, FeDeriCa

A new fixed-dose combination of subcutaneous (SC) of pertuzumab + trastuzumab demonstrated non-inferiority compared with the same regimen which was administered intravenously (IV), with comparable efficacy and safety. This new formulation offers patients with human epidermal growth factor 2 (HER2)-positive breast cancer a faster and simpler method of pertuzumab + trastuzumab administration.

Tan et al. presented the first results from the FeDeriCa study which was designed to assess the pharmacokinetics, efficacy, and safety of a novel SC fixed-dose combination of pertuzumab + trastuzumab compared with IV trastuzumab + pertuzumab in patients with HER2-positive early breast cancer in the neoadjuvant-adjuvant setting [1]. The new SC formulation was developed using recombinant human hyaluronidase in one vial and is administered into the thigh over 5-8 minutes. Eligible patients had centrally confirmed HER2-positive invasive breast cancer (tumour >2 cm, or node-posit...

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