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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.

New results from the phase 3 QuANTUM-R trial showed that quizartinib, an oral, selective FLT3 inhibitor, significantly extended overall survival compared with chemotherapy in patients with relapsed/refractory acute myeloid leukemia (AML) and the FLT3-ITD mutation.

This week Sellas Life Sciences Group announced data from a study of NeuVax (nelipepimut-S) in combination with Herceptin (trastuzumab) in patients with HER2 1+/2+ breast cancer.
A post hoc analysis of the phase 2 ALTA trial showed longer overall survival in crizotinib-refractory patients with advanced ALK-positive NSCLC who continued brigatinib versus discontinuing it after disease progression.
In treatment-naïve patients with NSCLC and high tumor mutation burden—regardless of PD-L1 expression—the combination of nivolumab plus ipilimumab showed superior PFS versus chemotherapy in the phase 3 CheckMate-227 trial.
Amid the changing landscape of treatments for ALK-positive NSCLC, sequencing of ALK inhibitors grows more complex and will require an assessment of individual patient’s tumor characteristics.
Seribantumab (MM-121), a drug under investigation in the phase 2 SHERLOC trial for the treatment of heregulin-positive NSCLC, was granted orphan drug designation from the FDA.
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