Today, Eli Lilly Canada Inc. announced that Health Canada has approved Lartruvo (olaratumab) to treat adults with soft tissue sarcoma when radiation therapy or surgery are not options. The approval comes in the form of a Notice of Compliance with Conditions which is a way for Health Canada to fast track an approval while waiting for additional data.
In this case, the approval was based on an exemplary phase 2 study showing the drug to improve overall survival but a phase 3 trial is currently underway to confirm the drug’s efficacy. Those results are expected in 2020.
In a news release, Diana Arajs, Chair of the Sarcoma Cancer Foundation of Canada said, “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.” Arajs added, “Health Canada’s decision to conditionally approve olaratumab based on phase 2 data is wonderful news for our community.”
In the United States, the Food and Drug Administration (FDA) approved the drug in October 2016. They also approved the drug under an accelerated program that will require confirmatory results from a phase 3 clinical trial.
The phase 2 study that led to the drug’s accelerated approval involved 133 patients with various forms of metastatic soft tissue sarcomas. The study observed that patients who received olaratumab plus doxorubicin had a median overall survival of 26.5 months compared to 14.7 months in patients receiving doxorubicin alone. Further, patients given olaratumab plus doxorubicin had a median progression-free survival (mPFS) of 8.2 months versus 4.4 months for patients given doxorubicin alone.
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 said, “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.”
Soft tissue sarcomas are a diverse group of rare cancers that usually develop in the connective tissue of the body. According to the Canadian Cancer Society, approximately 1,255 Canadians were diagnosed with soft tissue sarcoma in 2013, and 765 died from the condition.
Lartruvo (olaratumab) is a monoclonal antibody that binds to the platelet derived growth factor receptor-α (PDGFR-α) and prevents that protein from attaching to cancer cells and promote further growth.
For more information about soft tissue sarcoma, visit the Sarcoma Cancer Foundation of Canada.