- 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.
- 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.