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2019 Fourth Annual Oncology Guide to New FDA Approvals

FDA Updates

Welcome to the Fourth Annual Oncology Guide to New FDA Approvals

FDA Updates

New Indications Approved by the FDA in 2018 for Oncology Drugs

Dalia Buffery, MA, ABD

FDA Updates

FDA Approvals of Novel Brand-Name Prescription Cancer Drugs in 2018

FDA Updates, Melanoma

Braftovi (Encorafenib) plus Mektovi (Binimetinib) Third BRAF/MEK Inhibition Combination Approved for Metastatic Melanoma with BRAF Mutation

Lisa A. Raedler, PhD, RPh, Medical Writer

FDA Updates, Lymphoma

Copiktra (Duvelisib) Approved for Relapsed or Refractory CLL, SLL, and Follicular Lymphoma

Lisa A. Raedler, PhD, RPh, Medical Writer

FDA Updates, Leukemia

Daurismo (Glasdegib) Approved, in Combination with Low-Dose Cytarabine, for Newly Diagnosed Acute Myeloid Leukemia in Older Adults or Those Unfit for Intensive Chemotherapy

Loretta Fala, Medical Writer

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

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