LARTRUVO™ (olaratumab) approved in Canada for the treatment of advanced soft tissue sarcoma in adults
TORONTO, ON, January 24, 2018 – Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for LARTRUVO TM (olaratumab). 1 Olaratumab is a chemotherapy medicine used in combination with doxorubicin for the treatment of adult patients with soft tissue sarcoma when treatment with radiation or surgery are not options. 1 Soft tissue sarcoma is a rare cancer of muscles, fat or other tissues. 2 To receive olaratumab, treatment with an anthracycline, such as doxorubicin, must be an appropriate treatment option for the patient. 1 The conditional approval of olaratumab is based on the results of a Phase 2 study that showed a significant improvement in overall survival with a combination of doxorubicin plus olaratumab compared to doxorubicin alone. 3 A confirmatory Phase 3 trial is currently underway to further verify the clinical benefit of olaratumab.
“Olaratumab represents a shift in first line treatment for patients with advanced soft tissue sarcoma. The use of olaratumab alongside doxorubicin is highly significant, because it is the first time combination therapy has shown superior overall survival,” says Dr. Albiruni Ryan Abdul Razak, Medical Oncology Lead in Sarcoma at Princess Margaret Cancer Centre & Mount Sinai Hospital, part of Sinai Health System in Toronto, Ontario.
Olaratumab received approval under Health Canada’s NOC/c policy. This policy facilitates earlier access to new drugs for serious, life-threatening or severely debilitating illnesses on the basis of promising evidence of clinical effectiveness. Approval under this policy is granted on the condition that additional clinical trials be conducted to verify the anticipated benefit. A confirmatory Phase 3 trial is currently underway to further verify the clinical benefit of olaratumab. These study results are expected in 2020. 4
“Health Canada's decision to conditionally approve olaratumab based on phase 2 data is wonderful news for our community,” says Diana Arajs, Chair of the Sarcoma Cancer Foundation of Canada. “We are thrilled that this treatment is now available to Canadian patients, and that physicians will have more desperately needed options for difficult to treat soft tissue sarcomas.”
Sarcomas are a diverse and relatively rare type of cancer that usually develop in the connective tissue of the body, which include fat, blood vessels, nerves, bones, muscles, deep skin tissues and cartilage 2. Soft tissue sarcoma is a complex disease with multiple subtypes, making it very hard to diagnose and difficult to treat. 5 For decades there have been no front-line therapeutic advancements for soft tissue sarcoma that have improved overall survival. According to the Canadian Cancer Society, in 2013 an estimated 1,255 Canadians were diagnosed with soft tissue sarcoma, and 765 died from it. 6
About LARTRUVO (olaratumab)
LARTRUVO contains the active substance olaratumab, which belongs to a group of substances called monoclonal antibodies and is different from traditional chemotherapy. 1 Olaratumab binds to a protein on the surface of some cancer cells. 1 The protein is known as platelet derived growth factor receptor-α (PDGFR-α). 1 Other body proteins (called growth factors) can attach to the PDGFR-α. 1 Olaratumab prevents these proteins from binding to cancer cells. 1 This may prevent the growth of these cancer cells. 1
Olaratumab is administered by intravenous infusion, which lasts about 60 minutes. Treatment with olaratumab is given in combination with a chemotherapy medicine called doxorubicin for up to the first 8 treatment cycles. 1 A treatment cycle is 21 days (3 weeks). 1 A healthcare professional will determine an individual’s treatment plan.
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LARTRUVO Product Monograph. http://lilly.ca/en/pdf/product-monograph/lartruvo-ca-pm-approved.pdf. Accessed on January 19, 2018.
Canadian Cancer Society. What is soft tissue sarcoma? http://www.cancer.ca/en/cancer-information/cancer-type/soft-tissue-sarcoma/soft-tissue-sarcoma/?region=nb. Accessed January 19, 2018.
Tap WD, Jones RL, Van Tine BA, et al. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016;388(10043):488-497.
Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT02451943?term=olaratumab&rank=2. Accessed January 19, 2018.
Burningham Z, Hashibe M, Spector L, Schiffman JD. The Epidemiology of Sarcoma. Clinical Sarcoma Research. 2012;2:14. doi:10.1186/2045-3329-2-14.
Canadian Cancer Society. Soft Tissue Sarcoma Stats. http://www.cancer.ca/en/cancer-information/cancer-type/soft-tissue-sarcoma/statistics/?region=nb Accessed January 19, 2018.