FDA Approvals, News & Updates

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
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.
The FDA has granted accelerated approval of rucaparib (Rubraca), a poly ADP-ribose polymerase inhibitor, for the treatment of patients with advanced ovarian cancer whose tumors have deleterious BRCA gene mutation and have been treated with ≥2 chemotherapies. The administration also approved a companion diagnostic to the drug, FoundationFocus CDxBRCA, which is the first next-generation sequencing diagnostic test.
The FDA has granted approval to daratumumab (Darzalex) for the treatment of patients with multiple myeloma who have received ≥1 previous therapies, in combination with dexamethasone and either lenalidomide or bortezomib.
The US Food and Drug Administration has granted accelerated approval to pembrolizumab (Keytruda injection) for use in patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed after platinum-containing chemotherapy. The injection is recommended to be administered at 200 mg intravenously for 30 minutes every 3 weeks.
Daclizumab (Zinbryta) has been approved by the US Food and Drug Administration for adults with relapsing forms of multiple sclerosis. The drug is self-administered by the patient monthly, and comes in the form of a long-acting injection.
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