FDA Approvals, News & Updates

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.
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
  • FDA Resumes Operations After Government Shutdown Ends
  • FDA Approves New Drug Indication for Use in Hepatocellular Carcinoma
  • FDA Approves Pembrolizumab for Merkel-Cell Carcinoma
Talzenna Approved for HER2-Negative, Locally Advanced Breast Cancer with Germline BRCA Mutations
Udenyca, Second Biosimilar to Neulasta, FDA-Approved to Reduce Risk for Infection in Patients with Nonmyeloid Malignancies
Daurismo New Treatment Approved for Older Adults with Acute Myeloid Leukemia
Xospata First Therapy Approved for Relapsed or Refractory Acute Myeloid Leukemia with FLT3 Mutation
Truxima First Biosimilar to Rituxan FDA-Approved for Non-Hodgkin Lymphoma
Adcetris First FDA-Approved Drug for CD30-Expressing Peripheral T-Cell Lymphomas
Venclexta Approved in Combination for Older Adults with Acute Myeloid Leukemia
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.
On June 27, 2018, the FDA approved the combination of encorafenib and binimetinib (Braftovi and Mektovi; Array BioPharma), 2 new kinase inhibitors, for the treatment of patients with unresectable or metastatic melanoma and the BRAF V600E or BRAF V600K mutation, as detected by the companion diagnostic THxID BRAF Kit, which was approved on the same day.
In August, the FDA approved lenvatinib for the first-line treatment of patients with unresectable hepatocellular carcinoma, based on the results of the REFLECT clinical trial.
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