New formulation of RITUXAN now available to Canadians living with non-Hodgkin's Lymphoma

MISSISSAUGA, ON, Dec. 13, 2016 /CNW/ - Canadians living with non-Hodgkin's Lymphoma, one of the most commonly diagnosed blood cancers in Canada,1 now have a new option that may help them minimize time spent in the chemotherapy suite. Health Canada has approved the subcutaneous (under the skin) formulation of RITUXAN® (rituximab) in combination with chemotherapy agents for the treatment of patients with low-grade CD20 antigen positive B-cell non-Hodgkin's lymphoma, who have not received prior treatment or who are no longer responding to their current treatment or where the lymphoma has returned despite previous treatment.2

"Through clinical trials I've seen first-hand the potential benefit the reduced administration time of RITUXAN SC can provide patients," said Trisha Hudson, Registered Nurse, and Hematology Research Coordinator with the Nova Scotia Health Authority. "The subcutaneous formulation of RITUXAN can be administered in approximately five minutes, compared to a minimum of one and a half hours for the current intravenous formulation, reducing the amount of time required to receive treatment."

RITUXAN SC is the same active drug as RITUXAN (administered intravenously), developed by combining concentrated formula of the active drug with an innovative enzyme based technology to enable administration of large volumes under the skin.3 Health Canada's approval of RITUXAN SC is based on results from the SABRINA and SparkThera studies of follicular lymphoma. The SABRINA study showed that a fixed-dose RITUXAN SC formulation with a shortened administration time did not compromise the drug's efficacy or safety.4,5

"For Canadians living with non-Hodgkin lymphoma, it can be a challenge to manage their treatment while also managing commitments in other aspects of their life," says Robin Markowitz, CEO of Lymphoma Canada. "Any option that has the potential to reduce the amount of time required for patients to receive treatment would be welcome for this patient population as they combat their condition."

About the Health Canada Approval
On September 9, 2016, Health Canada approved the subcutaneous (SC) formulation of RITUXAN for:6

  • the treatment of patients with CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma (DLBCL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.
  • the treatment of patients with previously untreated Stage III/IV follicular, CD20 positive, B-cell non-Hodgkin's lymphoma in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy.
  • the maintenance treatment of patients with follicular non-Hodgkin's lymphoma who have responded to induction therapy with either CHOP or CHOP plus RITUXAN.
  • single-agent maintenance treatment of previously untreated patients with advanced follicular non-Hodgkin's lymphoma with high tumour burden and who have responded to induction therapy with either CHOP plus RITUXAN or CVP plus RITUXAN.

About RITUXAN® (rituximab)
RITUXAN is a therapeutic monoclonal antibody that binds to a particular protein – the CD20 antigen – on the surface of normal and malignant B-cells. When in place, RITUXAN works to stop the growth of the cancer cells and recruits the body's natural defenses to attack and kill the marked B-cells.7

For more than 15 years, the efficacy and safety of RITUXAN has been documented in more than 300 phase II/III clinical studies. RITUXAN has been approved for the treatment of several blood cancers, specifically, certain types of non-Hodgkin's lymphoma and for chronic lymphocytic leukemia.8 It continues to be studied in other types of blood cancers and disease areas where CD20-positive cells are believed to play a role.

About the SABRINA and SparkThera Studies
Health Canada's approval of RITUXAN SC is based on results from the SABRINA and SparkThera studies of follicular lymphoma (FL), including 16 clinical trial sites in Canada with 48 patients, which showed that a fixed-dose RITUXAN SC formulation with a shortened administration time did not compromise the drug's efficacy or safety.9,10 SparkThera was a two-stage Phase Ib trial to investigate the pharmacokinetics, safety and tolerability of RITUXAN SC in patients with follicular lymphoma as part of maintenance treatment.11 SABRINA, a pivotal, two-stage Phase III, international, multi-center, randomized, controlled, open-label study, was conducted in patients with previously untreated follicular lymphoma to investigate the non-inferiority of the pharmacokinetic profile, together with efficacy and safety of RITUXAN SC.12

The proportion of patients experiencing any grade adverse events was similar between the two treatment arms (RITUXAN SC: 93%; RITUXAN IV 92%). The most common adverse events, occurring in 20% of patients in either treatment arm, were neutropenia (RITUXAN SC: 31%; RITUXAN IV: 26%), nausea (RITUXAN SC 30%; RITUXAN IV 21%) and constipation (RITUXAN SC 23%; RITUXAN IV 25%).13 In SABRINA, severe administration-related reactions (Grade≥3) were reported in two patients (1%) following RITUXAN SC administration. These events were Grade 3 injection site rash and dry mouth. In SparkThera, no severe administration-related reactions were reported.14

About non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma, a blood cancer, is one of the most commonly diagnosed cancers in Canada.15 One in 43 men and one in 50 women will develop the disease in their lifetime.16

Non-Hodgkin's lymphoma is cancer that originates in the lymphatic system, the disease-fighting network spread throughout the body. Tumours develop from lymphocytes — a type of white blood cell.  It can start almost anywhere in the body, but is typically discovered in the neck, above the collarbone, under the arms, in the abdomen or groin.17

Many different subtypes of non-Hodgkin's lymphoma exist. The most common subtypes include diffuse large B-cell lymphoma and follicular lymphoma. The disease can also be classified as indolent or aggressive, a distinction made between fast and slow growing cells.18

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life, and survival of patients. Founded in 1886, Roche has been making important contribution to global health for more than a century. Twenty-eight medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy. In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

Roche Canada was founded in 1931. The company employs approximately 900 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 trademarks used or mentioned are legally protected.

References
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1 Canadian Cancer Statistics. Canadian Cancer Society, 2016.
http://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2016-EN.pdf?la=en Accessed October 24, 2016.

2 RITUXAN SC Product Monograph, September 9, 2016.

3 Salar A, Avivi I, Bittner B, Bouabdallah R, Brewster M, Catalani O, Follows G, Haynes A, Hourcade-Potelleret F, Janikova A, Larouche JF, McIntyre C, Pedersen M, Pereira J, Sayyed P, Shpilberg O, Tumyan G. 2014. Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study. J Clin Oncol. 10;32(17):1782-91. doi: 10.1200/JCO.2013.52.2631.

4 Salar A, Avivi I, Bittner B, Bouabdallah R, Brewster M, Catalani O, Follows G, Haynes A, Hourcade-Potelleret F, Janikova A, Larouche JF, McIntyre C, Pedersen M, Pereira J, Sayyed P, Shpilberg O, Tumyan G. 2014. Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study. J Clin Oncol. 10;32(17):1782-91. doi: 10.1200/JCO.2013.52.2631.

5 Davies A, Merli F, Mihaljevic B, Siritanaratkul N, Solal-Céligny P, Barrett M, Berge C, Bittner B, Boehnke A, McIntyre C, MacDonald D. 2014. Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study. Lancet Oncol. 15(3):343-52. doi: 10.1016/S1470-2045(14)70005-1.

6 RITUXAN SC Product Monograph, September 9, 2016.

7 RITUXAN IV Product Monograph, October 31, 2014.

8 RITUXAN IV Product Monograph, October 31, 2014.

9 Salar A, Avivi I, Bittner B, Bouabdallah R, Brewster M, Catalani O, Follows G, Haynes A, Hourcade-Potelleret F, Janikova A, Larouche JF, McIntyre C, Pedersen M, Pereira J, Sayyed P, Shpilberg O, Tumyan G. 2014. Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study. J Clin Oncol. 10;32(17):1782-91. doi: 10.1200/JCO.2013.52.2631.

10 Davies A, Merli F, Mihaljevic B, Siritanaratkul N, Solal-Céligny P, Barrett M, Berge C, Bittner B, Boehnke A, McIntyre C, MacDonald D. 2014. Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study. Lancet Oncol. 15(3):343-52. doi: 10.1016/S1470-2045(14)70005-1.

11 Salar A, Avivi I, Bittner B, Bouabdallah R, Brewster M, Catalani O, Follows G, Haynes A, Hourcade-Potelleret F, Janikova A, Larouche JF, McIntyre C, Pedersen M, Pereira J, Sayyed P, Shpilberg O, Tumyan G. 2014. Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study. J Clin Oncol. 10;32(17):1782-91. doi: 10.1200/JCO.2013.52.2631.

12 Davies A, Merli F, Mihaljevic B, Siritanaratkul N, Solal-Céligny P, Barrett M, Berge C, Bittner B, Boehnke A, McIntyre C, MacDonald D. 2014. Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study. Lancet Oncol. 15(3):343-52. doi: 10.1016/S1470-2045(14)70005-1.

13 RITUXAN SC Product Monograph, September 9, 2016.

14 RITUXAN SC Product Monograph, September 9, 2016.

15 Canadian Cancer Statistics. Canadian Cancer Society, 2016. http://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2016-EN.pdf?la=en Accessed October 24, 2016.

16 Canadian Cancer Society. Canadian Cancer Statistics, 2016. http://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2016-EN.pdf?la=en Accessed October 24, 2016 

17 Canadian Cancer Society. Non-Hodgkin's Lymphoma, 2016.
http://www.cancer.ca/en/cancer-information/cancer-type/non-hodgkin-lymphoma/non-hodgkin-lymphoma/?region=on Accessed October 24, 2016.

18 Canadian Cancer Society. Non-Hodgkin's Lymphoma, 2016.
http://www.cancer.ca/en/cancer-information/cancer-type/non-hodgkin-lymphoma/non-hodgkin-lymphoma/?region=on Accessed October 24, 2016.

SOURCE Roche Canada

For further information: Claire Cockburn, Roche Canada, 905-542-4648, Claire.cockburn@roche.com; Alexa Vogel, Edelman Public Relations, 416-850-0387, Alexa.vogel@edelman.com


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