FDA approves another trastuzumab biosimilar for HER2+ breast cancer


  • Miriam Davis, PhD
  • Oncology drug update
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Takeaway

  • On December 14, 2018, the FDA approved the trastuzumab biosimilar trastuzumab-pkrb (Herzuma®; Celltrion Inc. and Teva Pharmaceutical Industries Ltd) for 2 indications:
    • adjuvant HER+ node positive or node negative breast cancer, and
    • metastatic HER2+ breast cancer.

Why this matters

  • Trastuzumab-pkrb and the first biosimilar, trastuzumab-dkst (Ogivri®), may introduce further competition into the market, lowering costs and increasing access.
  • Unlike trastuzumab-dkst, trastuzumab-pkrb was not approved for HER2+ gastric cancer.

Key points

  • Trastuzumab-pkrb carries a boxed warning for:
    • cardiomyopathy, manifesting as congestive heart failure and decreased left ventricular ejection fraction, is riskiest when given with anthracyclines;
    • infusion reactions, pulmonary toxicity; and
    • embryo-fetal toxicity in the form of oligohydramnios, which can be complicated by pulmonary hypoplasia and neonatal death.
  • The approval of trastuzumab-pkrb was based on a data package that included a large phase 3 equivalence trial of 549 patients in 23 countries and that found that trastuzumab-pkrb and reference trastuzumab (Herceptin®) patients had similar rates of pathological complete response and similar proportions of serious adverse events (AEs), most commonly neutropenia.
  • The most common AEs (≥5%) in the adjuvant breast cancer group are headache, diarrhea, nausea, and chills.

Prescribing information, click here.

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