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FDA Updates

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

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

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

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

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

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

FDA Expands Indication for Kadcyla to Include the Adjuvant Treatment of HER2-Positive Early Breast Cancer

Tibsovo Now FDA Approved as First-Line Treatment for AML with IDH1 Mutation

FDA Approves Pembrolizumab plus Axitinib for Advanced Renal-Cell Carcinoma

April 16, 2019 – FDA Approvals, News & Updates

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