12/16/2025

Recent Oncology Related FDA Approvals and Expanded Indications

FDA Approves Amgen’s IMDELLTRA® (tarlatamab-dlle) in Extensive Stage Small Cell Lung Cancer

FDA Approves AstraZeneca’s Koselugo (selumetinib), for the Treatment of Adult Patients with Neurofibromatosis Type 1 (NF1) who have Symptomatic, Inoperable Plexiform

FDA Approves Genmab’s EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide for the Treatment of Relapsed or Refractory Follicular Lymphoma

FDA Approves Merck's KEYTRUDA® (pembrolizumab) with enfortumab vedotin-ejfv for Muscle Invasive Bladder Cancer

FDA Approves AstraZeneca's Imfinzi (durvalumab) for Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

FDA approves Lilly’s expanded indication for Jaypirca (pirtobrutinib) for adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor

FDA Approves Johnson & Johnson's Niraparib and Abiraterone Acetate Plus Prednisone for BRCA2-mutated Metastatic Castration-sensitive Prostate Cancer

FDA Approves Daiichi Sankyo's ENHERTU® Plus Pertuzumab Approved in the U.S. for First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

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