Health Canada Approves Trastuzumab for Subcutaneous Administration

Health Canada has approved a formulation of Roche’s originator trastuzumab, Herceptin, that is intended for subcutaneous administration. The drug, indicated to treat HER2-positive cancers, can be administered in 2 to 5 minutes (versus an average of 90 minutes for intravenous administration).
 
Kelly Davio
October 01, 2018
Last month, Health Canada approved a formulation of Roche’s originator trastuzumab, Herceptin, that is intended for subcutaneous administration. The drug, indicated to treat HER2-positive cancers, can be administered in 2 to 5 minutes (versus an average of 90 minutes for intravenous administration).

Mohammed Harb, MD, medical oncologist at the Dr Sheldon H. Rubin Oncology Clinic, said that the faster administration “can help free up resources in cancer centers, providing more flexibility to schedule patient appointments, and allowing healthcare professionals to accommodate more patients sooner."

The formulation, developed with Halozyme using proprietary technology that has been demonstrated to circumvent limitation on the volume of biologics that can be delivered under the skin, was approved on the basis of phase 3 results from the HannaH study. The trial demonstrated that the subcutaneous and intravenous versions of the drug had comparable efficacy and safety. 

In 2006, Roche entered into an agreement with Halozyme to develop subcutaneous versions of several of its top-selling biologics, and the subcutaneous trastuzumab launched in the European Union in 2013. Since then, use of the subcutaneous formulation has been shown to reduce healthcare provider time spent on administering trastuzumab, resulting in cost savings; a 2017 study conducted in 3 Spanish centers found that using the subcutaneous route of administration saved €979.60 (approximately $1137), and led to 24 hours of freed-up provider time, per patient per full treatment course.Other research has shown that subcutaneous administration has no negative impact on health-related quality of life for patients with early or metastatic breast cancer.2

However, as biosimilar trastuzumab has entered the European market, some evidence suggests that health systems are willing to forego faster administration to reap the rewards of even lower costs. Some estimates hold that biosimilar trastuzumab has already gained uptake of 70% in some EU nations due to deep discounts offered to health systems. However, like patients in the United States, Canadian patients do not yet have access to a biosimilar trastuzumab. 

The United States could soon gain access to the subcutaneous formulation of trastuzumab, however; in July 2018, Halozyme submitted a Biologics License Application for the subcutaneous formulation to the FDA on behalf of Roche and Genentech. 

References
1. Lopez-Vivanco G, Salvador J, Diez R, et al. Cost minimization analysis of treatment with intravenous or subcutaneous trastuzumab in patients with HER2-positive breast cancer in Spain. Clin Transl Oncol. 2017;19(12): 1454-1461. doi: 10.1007/s12094-017-1684-4.

1. Syrios J, Pappa E, Volakakis N, et al. Real-world data on health-related quality of life assessment in patients with breast cancer receiving subcutaneous trastuzumab. [Published online February 20, 2018.] Breast Cancer (Auckl). doi:10.1177/1178223418758031.

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