Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Biosimilar for Certain Breast Cancers

FDA news release; 2017 Dec 1

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.

Citation:

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.

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