Trastuzumab-dkst (Ogivri, Mylan, Biocon), a biosimilar to trastuzumab (Herceptin, Genentech Inc.), has been launched in the US, according to an announcement from Mylan N.V. and Biocon Ltd. It is the first biosimilar approved by the FDA and recommended by the FDA Oncologic Drugs Advisory Committee.

Trastuzumab-dkst is approved for all indications of trastuzumab, including the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer. Additionally, the FDA has recently approved 2 supplemental Biologics License Applications which expanded the manufacturing capability for trastuzumab-dkst.

The FDA approval was based on results from the HERITAGE study. The double-blind, randomized clinical trial was designed to evaluate the efficacy and safety of trastuzumab-dkst compared to trastuzumab. Participants were patients with centrally confirmed, measurable HER2-positive metastatic breast cancer without prior chemotherapy. Four-hundred and fifty-six patients were randomized to receive either trastuzumab-dkst or branded trastuzumab with docetaxel or paclitaxel for a minimum of 8 cycles.

The primary endpoint is an overall response rate at week 24 by blinded central evaluation using RECIST 1.1. Secondary endpoints include free survival, overall survival, and safety. According to the press release, the overall response rate in patients with HER2-positive metastatic breast cancer at week 24 was equivalent between the trastuzumab-dekst and trastuzumab groups. 

Trastuzumab-dkst is available in a 420mg multi-dose vial and a 150mg single-dose vial, providing patients with treatment flexibility. Both trastuzumab and biosimilar trastuzumab-dkst contain a boxed warning for cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity.

Reference

Mylan and Biocon launch trastuzumab biosimilar, Ogivri (trastuzumab-dkst), in the U.S. [news release]. Hertfordshire, England, Pittsburgh, PA, and Bengaluru, India: Mylan Press Release; December 2, 2019. http://newsroom.mylan.com/2019-12-02-Mylan-and-Biocon-Launch-Trastuzumab-Biosimilar-Ogivri-TM-trastuzumab-dkst-in-the-U-S. Accessed December 2, 2019.