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On March 8, 2019, the FDA granted accelerated approval to Genentech’s Tecentriq (atezolizumab), in combination with nab-paclitaxel (Abraxane), for the treatment of PD-L1–positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). This marks the first time an immunotherapy drug has been granted approval for the treatment of any form of breast cancer.
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Next-Generation Sequencing Testing in Oncology
Following the advent of molecularly targeted agents and, more recently, immunotherapy over the past few decades, we have witnessed dramatic changes in the treatment paradigms for many types of cancer.
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Clinical Application of Next-Generation Sequencing in Oncology
The clinical application of assays that utilize next-generation sequencing (NGS) technology is accelerating rapidly in the field of oncology.
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Use of Next-Generation Sequencing in Oncology
The advent of next-generation sequencing (NGS) technologies has revolutionized the way we approach and utilize molecular diagnostic testing in oncology.
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Approvals for new delivery methods for Herceptin and Cinvanti, and a new indication for Lonsurf close out the month of February in the FDA’s oncology-related activity.
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On February 15, 2019, the US Food and Drug Administration (FDA) approved the immunotherapy agent pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with resected stage III melanoma. This was the fourth approval pembrolizumab has received in the United States for the treatment of skin cancer, and the first FDA approval in the adjuvant setting.
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On February 12, 2019, the US Food and Drug Administration (FDA) granted approval for daratumumab (Darzalex; Janssen), a CD38-directed antibody, to be given in a split-dosing regimen to patients with multiple myeloma (MM). Darzalex is the first and only CD38-directed antibody to receive regulatory approval for the treatment of patients with MM and is the first to be approved for the split-dosing regimen. This new regimen gives patients and healthcare providers the option to split the first dose of Darzalex over the course of 2 consecutive days, which has the benefit of shortening the duration of the first infusion.
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About 2 years ago, the Academy of Oncology Nurse & Patient Navigators (AONN+) unveiled 35 evidence-based oncology navigation metrics.
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Page 181 of 281

Journal of Oncology Navigation & Survivorship
JONS

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