In this special episode of The Vitals, we ring in the New Year 2024 by combing through 2023 FDA approvals. Listen as editor, Lindsay Fischer, recounts key approvals on a month-by-month basis. To read the full information surrounding the approvals, be sure to check out our news coverage below. As always, thank you for listening to The Vitals, and for all the engagement in 2023. We look forward to bringing you more oncology news in 2024. We want to hear from you! Which drugs approved in 2023 have been practice changing? Have you had any difficulty or success in incorporating these novel agents into clinical use? Any challenges with supporting patients on these regimens? Email ONNeditors@mjhlifesciences.com with your feedback January Tucatinib and Trastuzumab Combination Gains FDA Approval for RAS Wild-Type HER2+ mCRCFDA Approves Zanubrutinib for CLL/SLLAdjuvant Pembrolizumab Gets FDA Approval in NSCLC FDA Grants Pirtobrutinib Accelerated Approval for Relapsed/Refractory MCL February Sacituzumab Govitecan Receives Indication for Unresectable, Locally Advanced or Metastatic HR+/HER2- Breast CancerFDA Grants Regular Approval to Dostarlimab for dMMR Endometrial Cancer March Abemaciclib Indication Expands to Include HR+, HER2–, Node+, High-Risk, Early Breast CancerFDA Approves Single-Dose Autoinjector of Biosimilar Pegfilgrastim-cbqv for Febrile NeutropeniaFDA Approves Dabrafenib With Trametinib for Pediatric BRAF V600E–Mutant Low-Grade GliomaFDA Grants Accelerated Approval to Retifanlimab for Locally Advanced Merkel Cell CarcinomaPembrolizumab Receives Full FDA Approval for Treatment of Select Patients With dMMR/MSI-H Solid Tumors April FDA Grants Accelerated Approval to Enfortumab Vedotin Plus Pembrolizumab for Locally Advanced or Metastatic Urothelial CancerOmidubicel-onlv Gets Greenlight to Accelerate Neutrophil Recovery After Stem Cell Transplant in Hematologic MalignanciesPolatuzumab Vedotin Approved in Combination With R-CHP for Treatment-Naïve DLBCL, High-Grade B-Cell Lymphoma May Cemiplimab Granted Full Approval for Metastatic Basal Cell CarcinomaEpcoritamab Obtains Accelerated Approval for Relapsed/Refractory DLBCLFDA Greenlights Avapritinib for Indolent Systemic MastocytosisFDA Approves Radiohybrid PET Diagnostic Agent Posluma for PSMA-Positive Lesions in Prostate CancerOlaparib Gains FDA Approval for BRCA+ mCRPC June Glofitamab Gains Accelerated Approval for Relapsed/Refractory DLBCLFDA Approves Talazoparib in Combination With Enzalutamide for mCRPCBlinatumomab Receives Full Approval for MRD-Positive B-Cell ALL July Ready-to-Dilute Cyclophosphamide Injections Obtain FDA ApprovalQuizartinib Plus Chemo Gains FDA Approval for Newly Diagnosed, FLT3-ITD+ AMLFDA Approves Frontline Dostarlimab in Combination With Chemotherapy for dMMR/MSI-H Endometrial Cancer August FDA Approves Trifluridine/Tipiracil With Bevacizumab for Metastatic Colorectal CancerPralsetinib Gains Regular Approval for NSCLC With RET Gene FusionsTalquetamab Receives Accelerated Approval for Heavily Pretreated Multiple MyelomaFDA Approves Niraparib Plus Abiraterone Acetate to Treat BRCA+ mCRPCFDA Grants Elranatamab Accelerated Approval for Relapsed or Refractory Multiple MyelomaFDA Approves Hepzato Kit for Metastatic Uveal Melanoma With Liver Metastases September FDA Approves Motixafortide Plus G-CSF to Mobilize Hematopoietic Stem Cells in Multiple MyelomaFDA Approves Momelotinib to Treat Myelofibrosis With AnemiaBosutinib Is Approved for Pediatric Ph+ CP–Chronic Myeloid Leukemia October FDA Grants Marketing Authorization to First DNA Test to Assess Multiple Cancer PredispositionsFDA Approves Encorafenib/Binimetinib for BRAF V600E+ NSCLCFDA Approves Adjuvant Nivolumab for Stage IIB/C MelanomaPembrolizumab/Chemotherapy is Approved for Neoadjuvant and Adjuvant Resectable Non-Small Cell Lung CancerEntrectinib Is Approved for Pediatric Patients With NTRK+ Solid TumorsFDA Approves Ivosidenib to Treat Myelodysplastic Syndromes With IDH1 MutationFDA Approves Toripalimab Regimens to Treat Adults With Nasopharyngeal Carcinoma November FDA Grants Pembrolizumab New Biliary Tract Cancer IndicationFDA Approves Fruquintinib for Patients With Pretreated Metastatic Colorectal CancerFDA Approves Repotrectinib for Adults With Advanced/Metastatic ROS1+ NSCLCPembrolizumab Is Approved for Patients With HER2– Gastric/GEJ AdenocarcinomaFDA Approves Capivasertib/Fulvestrant for Advanced/Metastatic, HR+, HER2- Breast CancerFDA Approves Enzalutamide for High-Risk Nonmetastatic Castration-Sensitive Prostate CancerFDA OKs Nirogacestat for Adults Patients With Desmoid Tumors December FDA Grants Pirtobrutinib Accelerated Approval to Treat CLL/SLL in the Third LineFDA Approves Eflornithine for Children, Adults With High-Risk NeuroblastomaFDA Approves Belzutifan for Patients With Advanced Renal Cell CarcinomaEnfortumab Vedotin Plus Pembrolizumab Snags Full Approval for Patients With Locally ...
