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EU Approves Trastuzumab Biosimilar for HER2+ Breast, Gastric Cancers

Jason Harris
Published: Wednesday, Aug 01, 2018

Diana Luftner, MD

Diana Lüftner, MD

PF-05280014 (Trazimera), a biosimilar for trastuzumab (Herceptin), has been approved for use in the European Union (EU) to treat patients with HER2 overexpressing metastatic or early breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

“Trazimera has the potential to help many patients with HER2 overexpressing cancers, such as breast and gastric, which can correlate with poor outcomes and aggressive disease,” Diana Lüftner, MD, Charité Campus Benjamin Franklin and member of the presidency of the German Society of Hematology and Medical Oncology, said in a statement. “Today’s approval will help enable greater access for patients and physicians across Europe, without compromising on quality, efficacy, and safety.”

The agent is approved as monotherapy for patients with metastatic breast cancer who have received at least 2 prior chemotherapy regimens, and in combination with paclitaxel or docetaxel for chemotherapy-naïve patients. It is also approved in combination with an aromatase inhibitor for trastuzumab-naïve postmenopausal patients with metastatic disease. For patients with early breast disease, the biosimilar is approved following surgery, chemotherapy, and radiotherapy, and in combination with adjuvant or neoadjuvant chemotherapy.

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