FDA Approves New Dose of Herceptin Biosimilar

The FDA has approved a 420 milligram multi-dose of Ontruzant, a biosimilar to Herceptin.

The Food and Drug Administration (FDA) approved a 420 milligram (mg) vial of Ontruzant (trastuzumab-dttb), a biosimilar to Herceptin (trastuzumab), according to a press release from the drug’s manufacturer.

The FDA previously approved a 150 mg single-dose vial of Ontruzant in January 2019 across all eligible indications, which included the adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, metastatic gastric cancer or gastroesophageal junction adenocarcinoma in those who have received no prior treatment for metastatic disease.

The initial approval was based on data sets from seven clinical trials, which demonstrated similarity in survival outcomes and safety between Ontruzant and reference Herceptin in patients with HER2-positive adjuvant and metastatic breast cancer, as well as HER2-positive metastatic gastric cancer.

Phase 3 data on the biosimilar was published in January 2018, in which the biosimilar inducted a rate of breast pathologic complete response (bpCR) similar to Herceptin in patients with HER2-positive breast cancer, and also demonstrated comparable safety outcomes.

From April 2014 to August 2015, 800 patients were randomized to eight cycles of Ontruzant (402 patients) or Herceptin (398 patients) concurrently with four cycles of docetaxel followed by four cycles of fluorouracil, epirubicin and cyclophosphamide. Patients then underwent surgery, followed by 10 cycles of adjuvant Ontruzant or Herceptin.