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Web Exclusives published on March 8, 2019 in FDA Approvals, In the News
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.
Web Exclusives published on March 6, 2019 in Immunotherapy, Multiple Myeloma
A dizzying array of new chimeric antigen receptor (CAR) T-cell therapies targeting the B-cell maturation antigen (BCMA) designed specifically for the treatment of multiple myeloma was presented at the 2018 American Society of Hematology (ASH) annual meeting. BCMA-targeted CAR T-cell therapies are designed to improve T-cell persistence, depth of response, and tolerability. Response rates reported at ASH 2018 range from 70% to 100%, depending on the patient population and the use of previous regimens.
Web Exclusives published on February 22, 2019 in FDA Approvals, In the News
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.
Web Exclusives published on February 20, 2019 in Lung Cancer
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.
Web Exclusives published on February 19, 2019 in FDA Approvals, In the News
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.
Web Exclusives published on February 1, 2019 in FDA Approvals, In the News
  • 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
Web Exclusives published on February 1, 2019 in FDA Approvals, In the News
  • FDA Resumes Operations After Government Shutdown Ends
  • FDA Approves New Drug Indication for Use in Hepatocellular Carcinoma
  • FDA Approves Pembrolizumab for Merkel-Cell Carcinoma
Web Exclusives published on January 28, 2019 in Breast Cancer
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.
Web Exclusives published on January 17, 2019 in Immunotherapy, Renal-Cell Carcinoma
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.
Web Exclusives published on January 14, 2019 in FDA Approvals, In the News
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.
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