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FDA Updates, Gastrointestinal Cancers

Lutathera (Lutetium Lu 177 Dotatate) First Radioactive Drug Approved for Gastroenteropancreatic Neuroendocrine Tumors

Lisa A. Raedler, PhD, RPh, Medical Writer

FDA Updates, Leukemia

Lumoxiti (Moxetumomab Pasudotox-tdfk) First CD22-Directed Cytotoxin FDA Approved for Relapsed or Refractory Hairy-Cell Leukemia

Lisa A. Raedler, PhD, RPh, Medical Writer

FDA Updates, Prostate Cancer

Erleada (Apalutamide) First Drug Approved by the FDA for Nonmetastatic Castration-Resistant Prostate Cancer

Loretta Fala, Medical Writer

FDA Updates, Lymphoma

Imbruvica (Ibrutinib) plus Rituxan (Rituximab) New Combination Approved for the Treatment of Waldenström’s Macroglobulinemia

Lisa A. Raedler, PhD, RPh, Medical Writer

FDA Updates

Infugem (Gemcitabine) First Formulation of Premixed, Ready-to-Administer Intravenous Chemotherapy Approved for Several Tumor Types

Lisa A. Raedler, PhD, RPh, Medical Writer

FDA Updates, Skin Cancer

Libtayo (Cemiplimab-rwlc), a PD-1 Inhibitor, First Drug Approved by the FDA for Patients with Advanced Cutaneous Squamous-Cell Carcinoma

Loretta Fala, Medical Writer

FDA Updates, Lung Cancer

Lorbrena (Lorlatinib) Approved for the Treatment of Metastatic Non–Small-Cell Lung Cancer with ALK Mutation

Loretta Fala, Medical Writer

FDA Updates, Leukemia

Tibsovo (Ivosidenib) First Targeted Therapy Approved for Patients with Relapsed or Refractory Acute Myeloid Leukemia and IDH1 Mutation

Lisa A. Raedler, PhD, RPh, Medical Writer

Breast Cancer, FDA Updates

Talzenna (Talazoparib) New PARP Inhibitor Approved for the Treatment of HER2-Negative Advanced Breast Cancer with Germline BRCA Mutation

Lisa A. Raedler, PhD, RPh, Medical Writer

FDA Updates, Lung Cancer

Vizimpro (Dacomitinib) Approved for First-Line Treatment of Metastatic Non–Small-Cell Lung Cancer with EGFR Mutation

Loretta Fala, Medical Writer

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