publication date: Jun. 22, 2016
Canadian Review Agency Delivers Positive Opinion for Opdivo in NSCLC
The Canadian Agency for Drugs and Technologies in Health made a positive recommendation for Opdivo (nivolumab) for the treatment of non-small cell lung cancer. The CADTH evaluation of Opdivo was made under the pan-Canadian Oncology Drug Review process.
In just over eight months, Opdivo has received Health Canada approval as a treatment for three distinct tumor types, including metastatic NSCLC, metastatic melanoma and advanced or metastatic renal cell carcinoma.
The Health Canada submissions received priority reviews, and the Opdivo lung and melanoma phase III studies were stopped early for demonstrating superior overall survival versus standard of care, according to Bristol-Myers Squibb Canada, the drug’s sponsor.
Genomic Health Inc. launched Oncotype SEQ Liquid Select, the first of several non-invasive liquid biopsy tests that the company plans to deliver through its Oncotype IQ Genomic Intelligence Platform.
Oncotype SEQ is a blood-based test that identifies and assesses actionable genomic alterations in a panel of 17 select genes to inform the treatment of stage IV solid tumors, including lung, breast, colon, melanoma, ovarian and gastrointestinal stromal tumors, according to Genomic Health.
The test is designed to provide information focused on genomic markers that have either been included in National Comprehensive Cancer Network guidelines or associated with sensitivity or resistance to relevant FDA-approved therapies. The test can also match eligible patients with actively enrolling phase II-IV clinical trials specific to their tumor type.
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