Health Canada Approves RITUXAN Subcutaneous Formulation for Canadians with Chronic Lymphocytic Leukemia

Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved RITUXAN^® (rituximab) subcutaneous (SC) for the treatment of patients with previously untreated or previously treated B-cell chronic lymphocytic leukemia (B-CLL), Binet Stage B or C, in combination with fludarabine and cyclophosphamide.²

RITUXAN SC is the same active drug as RITUXAN (administered intravenously), both in combination with chemotherapy, with a more convenient delivery method.³ The SC formulation enables administration of the drug in large volumes under the skin.⁴

"The approval of RITUXAN SC is exciting news and a meaningful advancement for those living with CLL, as intravenous treatments can take around four hours to receive, requiring patients to spend up to a half day sitting in the chemo suite," says Robin Markowitz, Chief Executive Officer, Lymphoma Canada. "The administration of RITUXAN SC only takes seven minutes, giving patients valuable time back in their day."

CLL is a cancer of the bone marrow and affects lymph cells (lymphocytes), which are a type of white blood cell.⁵ It is a type of blood cancer and is the most common type of leukemia.⁶ The disease is more common in men, and mainly occurs in people aged 60 and over. Approximately 2,200 Canadians are diagnosed with CLL each year.⁷

"We have seen RITUXAN SC to have a comparable efficacy and safety profile to the intravenous formulation," says Dr. Ronan Foley, a clinical haematologist at the Juravinski Cancer Centre. "It's good news for patients, physicians and the healthcare system that we can now offer a more efficient and less time consuming method of treatment administration for Canadians living with this form of blood cancer."

About the Health Canada Approval
The Health Canada approval of RITUXAN SC is based on data from the Phase Ib SAWYER study in 176 patients with chronic lymphocytic leukemia (CLL). The two-part Phase Ib, multicenter, randomized, open-label, parallel-group study was conducted in patients with previously untreated CLL to investigate the non-inferiority of the pharmacokinetic profile, together with efficacy and safety of RITUXAN SC in combination with chemotherapy.⁸ Exploratory assessment of the efficacy of RITUXAN SC compared with RITUXAN IV was evaluated as secondary objectives of the study. Data from the study demonstrated the following:

• Overall Response Rate (ORR) of 85.2 per cent (95 per cent CI: 76.1; 91.9) at the end of induction therapy with RITUXAN SC in comparison to 80.7 per cent (95 per cent CI: 70.9; 88.3) with RITUXAN IV
• Complete response rate of 26.1 per cent (95 per cent CI; 17.3; 36.6) after induction therapy with RITUXAN SC in comparison to 33.0 per cent (95 per cent CI; 23.3; 43.8) with RITUXAN IV.⁹

In Part 2 of the Phase Ib SAWYER study, the proportion of patients reporting an AE of any grade during the study was 96 per cent in the RITUXAN SC arm (82/85 patients) compared with 91 per cent in the RITUXAN IV arm (81/89 patients). The most common adverse events, occurring in > 20 per cent of patients in either treatment arm, were neutropenia (RITUXAN SC: 65 per cent; RITUXAN IV: 58 per cent), thrombocytopenia (RITUXAN SC: 24 per cent; RITUXAN IV: 26 per cent), pyrexia (RITUXAN SC: 32 per cent; RITUXAN IV: 25 per cent), nausea (RITUXAN SC: 38 per cent; RITUXAN IV: 35 per cent) and vomiting (RITUXAN SC: 21 per cent; RITUXAN IV: 22 per cent). The most common serious adverse event (SAE) overall was febrile neutropenia (RITUXAN SC: 11 per cent; RITUXAN IV: 4 per cent).

Local cutaneous reactions, including injection site reactions, were very common (≥ 1/10) in patients receiving RITUXAN SC. In the SAWYER study, local cutaneous reactions were reported in up to 42 per cent of patients in the RITUXAN SC arm. The most common local cutaneous reactions were: injection site erythema (26 per cent), injection site pain (16 per cent), and injection site swelling (5 per cent). Events seen following subcutaneous administration were mild or moderate, apart from two patients who experienced Grade 3 local cutaneous reactions (injection site erythema, injection site pain, and injection site swelling). Local cutaneous reactions of any Grade in the RITUXAN SC arm were most common during the first subcutaneous cycle (Cycle 2), followed by the second and the incidence decreased with subsequent injections. No cases of anaphylaxis or severe hypersensitivity reactions, cytokine release syndrome or tumour lysis syndrome were observed following subcutaneous administration during the RITUXAN SC development program.¹⁰

About RITUXAN^®
RITUXAN (rituximab) is a chimeric mouse/human monoclonal antibody that binds specifically to the transmembrane antigen CD20. When in place, RITUXAN works to stop the growth of the cancer cells and activates the body's natural defenses to attack and kill the marked B-cells. The use of RITUXAN in CLL is based on an improvement in progression-free survival.¹¹

Overall, survival benefit has not been demonstrated in patients with previous treatment for CLL. The efficacy of treatment with R-FC (RITUXAN-fludarabine and cyclophosphamide) in CLL patients who were previously treated with RITUXAN in combination with fludarabine and cyclophosphamide has not been studied.¹²

RITUXAN was approved by Health Canada for first-line treatment of CLL in 2009  and has been approved for the treatment of several blood cancers, specifically, certain types of non-Hodgkin's lymphoma and for chronic lymphocytic leukemia.¹³

About Chronic Lymphocytic Leukemia (CLL)
Chronic lymphocytic leukemia (CLL) is a cancer of the bone marrow affecting lymph cells (lymphocytes), which are a type of white blood cell.  There are two types: B-lymphocytes and T-lymphocytes. B-lymphocytes produce antibodies or proteins that help our immune system to fight foreign substances, which enter the body. All B-cells have a marker on their surface. This marker is called CD20.¹⁴

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

Register as Visitor to CPhI China 2018!