The US Food and Drug Administration has approved Ogivri (trastuzumab-dkst), the first biosimilar for the treatment of certain breast and stomach cancers.
Indications: Ogivri (trastuzumab-dkst) was approved as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+).
Dosage and administration: For intravenous (IV) infusion only. Do not administer as an IV push or bolus.
Adjuvant Treatment of HER2-Overexpressing Breast Cancer
Administer at either:
- Initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly for 12 weeks (with paclitaxel or docetaxel) or 18 weeks (with docetaxel/carboplatin). 1 week after the last weekly dose of Ogivri, administer 6 mg/kg as an IV infusion over 30 to 90 minutes every 3 weeks to complete a total of 52 weeks of therapy, or
- Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks for 52 weeks.
Metastatic HER2-Overexpressing Breast Cancer
- Initial dose of 4 mg/kg as a 90 minute IV infusion followed by subsequent weekly doses of 2 mg/kg as 30 minute IV infusions.
Adverse reactions: In adjuvant breast cancer, the most common adverse reactions (≥5%) are headache, diarrhea, nausea, and chills. In metastatic breast cancer, the most common adverse reactions (≥10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.
US Food and Drug Administration. FDA approves first biosimilar for the treatment of certain breast and stomach cancers. FDA Web site. December 1, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587378.htm. Accessed December 6, 2017.