FDA Approvals, News & Updates

  • 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.
The FDA recently approved 2 new biosimilars for managing different conditions related to cancer—epoetin alfa-epbx (Retacrit) is the first biosimilar to epoetin alfa (Epogen, Procrit) and pegfilgrastim-jmbd (Fulphila) is the first biosimilar to pegfilgrastim (Neulasta).
In the FDA’s dynamic regulatory environment, the patient voice has been adopted and end points for clinical trials have evolved from overall survival to other efficacy measures. “Having multiple drugs is a good thing. Many are approved on nonsurvival end points, and they have transformed the diseases,” said Richard Pazdur, MD.
The Lynx Group is pleased to bring you the Third Annual Oncology Guide to New FDA Approvals. The goal of this Guide is to offer oncologists, pharmacists, oncology nurses, and other healthcare stakeholders a comprehensive overview of new hematology oncology drugs approved by the US Food and Drug Administration (FDA) in 2017. This practical tool offers a quick, yet detailed, evidence-based resource for oncology providers to guide their management of patients with cancer.
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