Health Canada Approves OPDIVO (nivolumab) plus YERVOY (ipilimumab) Combined with Limited Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer
CheckMate -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. Health?Canada?and Project Orbis Collaboration Aims to Provide Earlier Availability to Cancer Treatments4
Project Orbis is an initiative of the United States Food and Drug Administration (FDA) Oncology Center of Excellence. 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. 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. 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. About Bristol Myers Squibb Canada Co.
Bristol Myers Squibb Canada Co. 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. Bristol Myers Squibb Canada Co. employs more than 400 people across the country. For more information, please visit?https://www.bms.com/ca/en. About Bristol Myers Squibb
Bristol?Myers Squibb?is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at?BMS.com?or follow us on?LinkedIn,?Twitter,?YouTube,?Facebook?and?Instagram. Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company. References:
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1?Canadian Product Monograph. Revised August 6, 2020.?https://www.bms.com/assets/bms/ca/documents/productmonograph/OPDIVO_EN_PM.pdf |
2Canadian Cancer Society. Immunotherapy.?https://www.cancer.ca/en/cancer-information/diagnosis-a nd-treatment/chemotherapy-and-other-drug-therapies/immunotherapy/?region=on. Accessed May 26, 2020. |
3?Reck M, Tudor-Eilade C, Cobo Dols M, et al. Nivolumab (NIVO) + ipilimumab (IPI) + 2 cycles of platinum-doublet chemotherapy (chemo) vs 4 cycles of chemo as first-line (1L) treatment (tx) for stage IV/recurrent non-small cell lung cancer (NSCLC): CheckMate 9LA [abstract]. In: American Society of Clinical Oncology (ASCO) Annual Meeting; May 29 ? June 2, 2020; Virtual. |
4?U.S. Food and Drug Administration. Project Orbis.?https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis. Accessed May 26, 2020. |