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.
Brigatinib, Next-Generation ALK Inhibitor, Improves Survival versus Crizotinib in Patients with NSCLC and ALK Mutation
Brigatinib (Alunbrig), a new-generation ALK inhibitor, significantly prolonged survival compared with standard of care with crizotinib (Xalkori) as first-line therapy in patients with advanced ALK-positive non–small-cell lung cancer (NSCLC). The median progression-free survival (PFS) was not reached in the brigatinib arm versus 9.8 months in the crizotinib arm. At 1 year, 67% of the patients who received brigatinib were still alive compared with 43% of patients who received crizotinib.
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.
- 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
The large, randomized TAM-01 clinical trial demonstrated that 5 mg daily of tamoxifen for 3 years halved the risk for recurrence of breast intraepithelial neoplasia—atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), and lobular carcinoma in situ—in women after surgery and reduced the risk for new contralateral breast cancer by 75% compared with placebo.
Combining an immune checkpoint inhibitor and a tyrosine kinase inhibitor (TKI) significantly improved progression-free survival (PFS) in treatment-naïve patients with advanced renal-cell carcinoma (RCC) compared with a TKI alone.
Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, on indefinite hold.
The combination of immunotherapy with nivolumab (Opdivo) and ipilimumab (Yervoy) may soon represent a new first-line treatment option in patients with early-stage metastatic colorectal cancer (CRC) associated with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) tumors. Two studies presented at the ESMO 2018 Congress demonstrated the efficacy of this combination in this patient population.
Web Exclusives published on December 12, 2018
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. She presented results from a 4-month study conducted at Stanford Health Care. Over the course of the study, patients were able to decrease their opioid use after surgery by 46%, without compromising pain control.
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Results 11 - 20 of 115
Results 11 - 20 of 115