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™ (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.”

About Sarcoma

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 cartilage2. 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.

The full Canadian Product Monograph for LARTRUVO™ (olaratumab) is available here.

About Lilly

Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people’s needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada Inc. was established in 1938, the result of a research collaboration with scientists at the University of Toronto, which eventually produced the world’s first commercially-available insulin. Lilly Canada now employs nearly 400 people across the country, working in the areas of oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.

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For more information, please contact: 

Alanna Fox                                                   
Cohn & Wolfe                                                
alanna.fox@cohnwolfe.ca                              
(416) 924-5700 ext 4078                              

Helen Stone
Eli Lilly Canada Inc.
stone_helen@lilly.com
(416) 693-3169


References

1 LARTRUVO Product Monograph. http://lilly.ca/en/pdf/product-monograph/lartruvo-ca-pm-approved.pdf. Accessed on January 19, 2018.
2 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.
3 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.
4 Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT02451943?term=olaratumab&rank=2. Accessed January 19, 2018.
5 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.
6 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.