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FDA Approves Fourth Trastuzumab Biosimilar

Gina Columbus @ginacolumbusonc
Published: Monday, Mar 11, 2019

The FDA has granted an approval to PF-05280014 (Trazimera; trastuzumab-qyyp), a trastuzumab (Herceptin) biosimilar, to treat patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.1 This marks the fourth approval by the FDA for a trastuzumab biosimilar.

In the phase III REFLECTIONS B327-02 trial, 707 patients with HER2-positive metastatic breast cancer were randomized 1:1 to receive paclitaxel plus PF-05280014 or trastuzumab-EU. All patients received weekly trastuzumab for at least 33 weeks at a starting dose of 4 mg/kg and subsequent doses of 2 mg/kg. Additionally, therapy continued until disease progression.

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