FDA Updates
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.
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
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
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.
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.
