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2019 Fourth Annual Oncology Guide to New FDA Approvals

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

FDA Updates, Leukemia

Xospata (Gilteritinib) First Drug Approved as Monotherapy for Adults with Relapsed or Refractory Acute Myeloid Leukemia with FLT3 Mutation

Lisa A. Raedler, PhD, RPh, Medical Writer

FDA Updates

Vitrakvi (Larotrectinib) First TRK Inhibitor Approved by the FDA for Solid Tumors Based on a Genetic Mutation

Lisa A. Raedler, PhD, RPh, Medical Writer

FDA Updates

Udenyca (Pegfilgrastim-cbqv) Second Biosimilar Approved to Reduce the Incidence of Infection Associated with Febrile Neutropenia

Lisa A. Raedler, PhD, RPh, Medical Writer

FDA Updates, Prostate Cancer

Yonsa (Fine-Particle Abiraterone Acetate) New Formulation Approved for Metastatic Prostate Cancer

Loretta Fala, Medical Writer

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