FDA Approves Trastuzumab-dkst as First Biosimilar for HER2+ Breast and GI Cancers

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Trastuzumab-dkst is the second biosimilar product to receive FDA approval for cancer therapy, and is the first approved for the treatment of breast and stomach cancers.
Trastuzumab-dkst is the second biosimilar product to receive FDA approval for cancer therapy, and is the first approved for the treatment of breast and stomach cancers.

The US Food and Drug Administration (FDA) approved trastuzumab-dkst — a biosimilar to trastuzumab — for the treatment of patients with HER2-positive (HER2+) breast or metastatic gastric or gastroesophageal junction adenocarcinoma.1

Trastuzumab-dkst is the second biosimilar product to receive FDA approval for cancer therapy, and is the first approved for the treatment of breast and stomach cancers.

FDA approval was based on evidence from analyses demonstrating that trastuzumab-dkst not only had similar structure, function, and activity in both animal and human pharmacokinetic/pharmacodynamic studies, but was also as safe and effective as the reference product.

The most frequently reported adverse events among patients with HER2+ breast cancer treated with trastuzumab-dkst included diarrhea, nausea, headache, fever, chills infection, cough, rash, congestive heart failure, and insomnia.

The most frequently reported adverse events among patients with HER2+ metastatic gastric cancer included neutropenia, anemia, thrombocytopenia, diarrhea, fatigue, weight loss, stomatitis, fever, mucosal inflammation, upper respiratory tract infection, nasopharyngitis, and dysgeusia.

Trastuzumab-dkst also comes with the Black Box Warnings of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity.

Reference

  1. FDA approves first biosimilar for the treatment of certain breast and stomach cancers [press release]. Silver Spring, MD: US Food and Drug Administration; December 1, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587378.htm. Accessed December 1, 2017.

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