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FDA Approves Trastuzumab Biosimilar for HER2+ Breast Cancer

Kristi Rosa
Published: Monday, Dec 17, 2018

The FDA has granted an approval to CT-P6 (Herzuma; trastuzumab-pkrb), a trastuzumab (Herceptin) biosimilar, for the treatment of patients with HER2-overexpressing breast cancer, according to Celltrion and Teva Pharmaceutical Industries, the co-developers of the agent.1

CT-P6 is indicated for patients with adjuvant breast cancer of HER2 overexpressing node-positive or -negative breast cancer to be used as part of a treatment regimen comprised of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, or as part of a regimen with docetaxel and carboplatin.

The biosimilar is also indicated as first-line treatment for patients with HER2-overexpressing metastatic breast cancer to be used in combination with paclitaxel, or as a single agent to treat HER2-positive breast cancer in patients who have received 1 or more chemotherapy regimens for metastatic disease.

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TitleExpiration DateCME Credits
Medical Crossfire®: Addressing Uncertainties in Oncology BiosimilarsApr 30, 20201.5
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