employs more than 400 people across the country. is an indirect wholly-owned subsidiary of Bristol Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Future drug development may benefit by establishing a greater uniformity of new global standards of treatment, leading to the optimal design of these important trials.īristol Myers Squibb Canada Co. Pivotal clinical trials in oncology are commonly conducted internationally and these global trials are increasingly important for investigating the safety and effectiveness of cancer drugs for approval across jurisdictions. This submission was part of the FDA's Project Orbis initiative, enabling concurrent review by the FDA and the health authorities in Australia, Canada and Singapore. Project Orbis is an initiative of the United States Food and Drug Administration (FDA) Oncology Center of Excellence. Health Canada and Project Orbis Collaboration Aims to Provide Earlier Availability to Cancer Treatments 4 "We welcome this new Health Canada approval for a novel treatment regimen for patients where there is still significant unmet need."ĬheckMate -9LA (NCT03215706) is Phase III, randomized open-label, multi-centre study evaluating OPDIVO® plus YERVOY® combined with two cycles of platinum-doublet chemotherapy versus chemotherapy (four cycles followed by optional pemetrexed maintenance therapy if eligible) as a first-line treatment in patients with metastatic or recurrent NSCLC regardless of PD-L1 expression and histology. "Receiving a diagnosis of advanced lung cancer is devastating," says Shem Singh, Executive Director, Lung Cancer Canada. "We are committed to pursuing innovative approaches to lung cancer treatment so we can continue to deliver the right medicines for patients, increase their quality of life, and improve their chances of survival." We are so proud to build on this legacy as OPDIVO ® plus YERVOY ® is approved as the first dual immunotherapy in a first-line NSCLC setting," said Al Reba, General Manager, BMS Canada. "Over four years ago, OPDIVO ® became the first immunotherapy approved for use in previously treated patients, defining a new era and changing the way NSCLC is treated. 3 With longer follow-up (minimum of 12.7 months), the dual immunotherapy with two cycles of chemotherapy continued to show sustained overall survival (OS) improvements over chemotherapy alone (median OS of 15.6 months versus 10.9 months, respectively ). Study results showed a statistically significant improvement in OS for metastatic NSCLC patients treated with OPDIVO ®, YERVOY ® and chemotherapy compared to chemotherapy alone at a prespecified interim analysis (at a minimum follow-up of 8.1 months, ). The study met both its primary and key secondary endpoints, demonstrating superior overall survival (OS), progression-free survival (PFS) and overall response rate (ORR) for the dual immunotherapy plus limited chemotherapy combination versus chemotherapy alone. The Health Canada approval was based on results from the randomised phase III clinical trial CheckMate -9LA. "This approval provides a novel dual immuno-oncology-based option that may provide longer survival for patients within the Canadian treatment landscape." Rosalyn Juergens, Associate Professor at McMaster University in the Department of Oncology, Division of Medical Oncology. "Despite NSCLC being the most common form of lung cancer, every patient's lung cancer and treatment journey is unique," says Dr. 2 This approval marks the availability of the first dual immuno-oncology plus limited course chemotherapy NSCLC treatment in Canada. 1 Unlike traditional cancer therapies that target the tumour directly, immuno-oncology activates the body's own immune system to help recognize and attack cancer cells. 11, 2020 /CNW/ - Today, Bristol Myers Squibb Canada (BMS) announces Health Canada's approval of OPDIVO ® (nivolumab) in combination with YERVOY ® (ipilimumab) with two cycles of platinum-double chemotherapy for the treatment of patients with metastatic non-small cell lung cancer (NSCLC), with no Epidermal Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) tumour aberrations and no prior systemic therapy for metastatic NSCLC. CheckMate -9LA trial results demonstrated superior overall survival versus chemotherapy, regardless of PD-L1 expression or tumor histology 1
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