HERCEPTIN® (trastuzumab) subcutaneous (SC) formulation approved in Canada for the treatment of HER2-positive breast cancer

SC formulation takes two to five minutes to administer, rather than up to 90 minutes with the standard intravenous (IV) formulation

MISSISSAUGA, ON, Sept. 13, 2018 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved a subcutaneous formulation of HERCEPTIN for the treatment of early and metastatic stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer, an aggressive form of the disease.^1,2

HERCEPTIN SC is a ready-to-use formulation that is administered under the skin via injection and demonstrated comparable safety and efficacy to HERCEPTIN IV.^3,4,5 With the SC formulation, healthcare professionals spend less time preparing and administering treatment compared to HERCEPTIN IV.⁶ In fact, HERCEPTIN SC administration takes two to five minutes rather than up to 90 minutes with the IV formulation, which may help reduce the amount of time patients spend in hospital.⁷

"As a physician, I see that many treatment facilities are functioning at complete capacity, which can lead to challenges for patients and the healthcare system on both the local level and as a whole," says Dr. Mohammed Harb, Medical Oncologist at the Dr. Sheldon H Rubin Oncology Clinic, Moncton. "A treatment like HERCEPTIN SC can help free up resources in cancer centers, providing more flexibility to schedule patient appointments, and allowing healthcare professionals to accommodate more patients sooner."

Breast cancer is the most common cancer among Canadian women. In 2017, more than 26,000 new cases of breast cancer were diagnosed, representing 25% of all new cancer cases in women.⁸ In HER2-positive breast cancer, increased quantities of the human epidermal growth factor receptor 2 (HER2) are present on the surface of the tumour cells. This is known as "HER2 positivity" and affects approximately 20 per cent of women with breast cancer.⁹

 "We know how important quality time with family and friends is for women living with breast cancer," says Cathy Ammendolea, Chair of the Board of Directors, Canadian Breast Cancer Network. "This new treatment option is good news as it offers less time preparing and administering treatment which allows patients to spend less time in the hospital and more time living their lives."

The approval of HERCEPTIN SC is based on longer term results from the Phase III HannaH study, which showed that the subcutaneous formulation demonstrated comparable efficacy to HERCEPTIN administered intravenously in women with HER2-positive early breast cancer.¹⁰ The drug concentration in the blood measured after 8 cycles of HERCEPTIN treatment, just before surgery, was higher with SC than with the IV formulation (78.7 and 57.8 µg/mL, respectively). Efficacy as determined by pathological complete response (pCR) in patients treated in the SC arm was in the same range as in patients who received the IV formulation (42.2 per cent and 37.4 per cent, respectively).¹¹

The safety profile in both arms was consistent with that expected from standard treatment with HERCEPTIN and chemotherapy in this setting and no new safety signals were identified. The most commonly reported severe (Grade ≥3) events were severe neutropenia (HERCEPTIN 33.2%; HERCEPTIN SC 29.3%), leukopenia (HERCEPTIN 6.0%; HERCEPTIN SC 4.0%) and febrile neutropenia (HERCEPTIN 4.4%; HERCEPTIN SC 5.7%). Serious adverse events (SAEs) were experienced in 14.4% of patients in the HERCEPTIN arm and 21.9% in the HERCEPTIN SC arm with the most frequently reported SAE (>1% and <10%) being febrile neutropenia (HERCEPTIN 3.7% and HERCEPTIN SC 4.4%) and neutropenia (HERCEPTIN 2.7% and HERCEPTIN SC 2.4%).¹²

About HERCEPTIN
HERCEPTIN is a humanized monoclonal antibody designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential when it is overexpressed. HERCEPTIN attaches to the HER2 receptor on the cancer cell and suppresses HER2 signaling to target and destroy the tumour.¹³ 

The SC form of HERCEPTIN is a ready-to-use liquid formulation that is administered as a 5 ml fixed dose every three weeks.¹⁴ This product removes the need for reconstitution or dose calculation according to the body weight of individual¹⁵ and an IV loading dose is not required when using SC administration.¹⁶

The SC formulation uses technology that temporarily and reversibly degrades hyaluronan, a gel-like substance that forms a barrier between cells under the skin. This enables the 5 ml volume of the SC formulation of HERCEPTIN to be rapidly dispersed and absorbed over a greater area.¹⁷

About Roche
Headquartered in Basel, Switzerland, Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Roche Canada was founded in 1931. The company employs over 1,000 people across the country, with its pharmaceuticals head office located in Mississauga, Ontario, and diagnostics division based in Laval, Quebec. Roche Canada is actively involved in local communities, investing in charitable organizations and partnering with healthcare institutions across the country. For more information, visit www.rochecanada.com.

 All trade-marks mentioned are the property of their respective owners.

© Copyright 2018, Hoffmann-La Roche Limited

REFERENCES

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¹ HERCEPTIN SC (trastuzumab injection) Product Monograph. Hoffmann-La Roche Limited. September 11, 2018.

² Slamon D et al. Adjuvant Trastuzumab in HER2-Positive Breast Cancer. N Engl J Med 2011; 365:1273-83. 

³ Pivot, Semiglazov et al. Subcutaneous injection of trastuzumab – analysis of administration time and injection site reactions. 

⁴ De Cock, Pivot et al. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Medicine 2016; 5(3):389–397.

⁵ Ismael, Hegg et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I–III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol 2012; 13: 869–78. 

⁶ De Cock, Pivot et al. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Medicine 2016; 5(3):389–397. 

⁷ De Cock, Pivot et al. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Medicine 2016; 5(3):389–397. 

⁸ Canadian Cancer Society. Breast Cancer Statistics. http://www.cancer.ca/en/cancer-information/cancer-type/breast/statistics/?region=on. Accessed on June 6, 2018.

⁹ X. Zhu, MD and S. Verma, MD MSEd. Targeted therapy in her2-positive metastatic breast cancer: a review of the literature. Curr Oncol. 2015 Mar; 22:(Suppl 1): S19–S28. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4381788/pdf/conc-22-s19.pdf. 

¹⁰ Ismael, Hegg et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I–III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol 2012; 13: 869–78.

¹¹ Ismael, Hegg et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I–III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol 2012; 13: 869–78.

¹² HERCEPTIN SC (trastuzumab injection) Product Monograph. Hoffmann-La Roche Limited. September 11, 2018. 

¹³ HERCEPTIN SC (trastuzumab injection) Product Monograph. Hoffmann-La Roche. September 11, 2018.

¹⁴ HERCEPTIN SC (trastuzumab injection) Product Monograph. Hoffmann-La Roche Limited. September 11, 2018. 

¹⁵ Pan S, Zhu L, Chen M, Xia P, Zhou Q. Weight-based dosing in medication use: what should we know? Patient preference and adherence. 2016;10:549-560. 

¹⁶ HERCEPTIN SC (trastuzumab injection) Product Monograph. Hoffmann-La Roche Limited. September 11, 2018. 

¹⁷ Pivot, Semiglazov et al. Subcutaneous injection of trastuzumab – analysis of administration time and injection site reactions.

SOURCE Roche Canada

please contact: Claire Cockburn, Roche Canada, 905-542-4648, [email protected]