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Articles

The advent of next-generation sequencing (NGS) technologies has revolutionized the way we approach and utilize molecular diagnostic testing in oncology. Read More ›

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. Read More ›

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. Read More ›

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. Read More ›

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. Read More ›

  • FDA Approves First Therapy for the Treatment of Adult Patients with a Rare Blood Clotting Disorder
  • FDA Issues Letter to Healthcare Providers Alerting Them to a Risk for Breast Implant Associated–Anaplastic Large-Cell Lymphoma
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  • FDA Resumes Operations After Government Shutdown Ends
  • FDA Approves New Drug Indication for Use in Hepatocellular Carcinoma
  • FDA Approves Pembrolizumab for Merkel-Cell Carcinoma
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Adding Immunotherapy to Chemotherapy Extends Survival in Metastatic Triple-Negative Breast Cancer
Triple-negative breast cancer is considered one of the most difficult to treat breast cancers, with few treatment options, but finally a breakthrough study shows progress by extending patient survival. Read More ›

FDA Perspective: Reducing Cost, Increasing Access to Cancer Care
In a time when the country feels more politically divided than ever, there is broad consensus that Medicare should be allowed to negotiate prescription drug prices directly with drug makers, and that the FDA should expedite approvals of generic cancer drugs to lower patients’ out-of-pocket costs. Read More ›

Patients can be successfully managed with minimal opioid medication after urologic oncology surgery, said Kerri Stevenson, MN, NP-C, RNFA, CWOCN, Lead Advanced Practice Provider – Interventional Radiology, Stanford Health Care, CA, at the 2018 ASCO Quality Care Sym­posium. Read More ›

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