What New Cancer Drugs Were Approved in 2023?

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+ mCRC
• FDA Approves Zanubrutinib for CLL/SLL
• Adjuvant 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 Cancer
• FDA Grants Regular Approval to Dostarlimab for dMMR Endometrial Cancer

March

• Abemaciclib Indication Expands to Include HR+, HER2–, Node+, High-Risk, Early Breast Cancer
• FDA Approves Single-Dose Autoinjector of Biosimilar Pegfilgrastim-cbqv for Febrile Neutropenia
• FDA Approves Dabrafenib With Trametinib for Pediatric BRAF V600E–Mutant Low-Grade Glioma
• FDA Grants Accelerated Approval to Retifanlimab for Locally Advanced Merkel Cell Carcinoma
• Pembrolizumab 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 Cancer
• Omidubicel-onlv Gets Greenlight to Accelerate Neutrophil Recovery After Stem Cell Transplant in Hematologic Malignancies
• Polatuzumab 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 Carcinoma
• Epcoritamab Obtains Accelerated Approval for Relapsed/Refractory DLBCL
• FDA Greenlights Avapritinib for Indolent Systemic Mastocytosis
• FDA Approves Radiohybrid PET Diagnostic Agent Posluma for PSMA-Positive Lesions in Prostate Cancer
• Olaparib Gains FDA Approval for BRCA+ mCRPC

June

• Glofitamab Gains Accelerated Approval for Relapsed/Refractory DLBCL
• FDA Approves Talazoparib in Combination With Enzalutamide for mCRPC
• Blinatumomab Receives Full Approval for MRD-Positive B-Cell ALL

July

• Ready-to-Dilute Cyclophosphamide Injections Obtain FDA Approval
• Quizartinib Plus Chemo Gains FDA Approval for Newly Diagnosed, FLT3-ITD+ AML
• FDA Approves Frontline Dostarlimab in Combination With Chemotherapy for dMMR/MSI-H Endometrial Cancer

August

• FDA Approves Trifluridine/Tipiracil With Bevacizumab for Metastatic Colorectal Cancer
• Pralsetinib Gains Regular Approval for NSCLC With RET Gene Fusions
• Talquetamab Receives Accelerated Approval for Heavily Pretreated Multiple Myeloma
• FDA Approves Niraparib Plus Abiraterone Acetate to Treat BRCA+ mCRPC
• FDA Grants Elranatamab Accelerated Approval for Relapsed or Refractory Multiple Myeloma
• FDA Approves Hepzato Kit for Metastatic Uveal Melanoma With Liver Metastases

September

• FDA Approves Motixafortide Plus G-CSF to Mobilize Hematopoietic Stem Cells in Multiple Myeloma
• FDA Approves Momelotinib to Treat Myelofibrosis With Anemia
• Bosutinib Is Approved for Pediatric Ph+ CP–Chronic Myeloid Leukemia

October

• FDA Grants Marketing Authorization to First DNA Test to Assess Multiple Cancer Predispositions
• FDA Approves Encorafenib/Binimetinib for BRAF V600E+ NSCLC
• FDA Approves Adjuvant Nivolumab for Stage IIB/C Melanoma
• Pembrolizumab/Chemotherapy is Approved for Neoadjuvant and Adjuvant Resectable Non-Small Cell Lung Cancer
• Entrectinib Is Approved for Pediatric Patients With NTRK+ Solid Tumors
• FDA Approves Ivosidenib to Treat Myelodysplastic Syndromes With IDH1 Mutation
• FDA Approves Toripalimab Regimens to Treat Adults With Nasopharyngeal Carcinoma

November

• FDA Grants Pembrolizumab New Biliary Tract Cancer Indication
• FDA Approves Fruquintinib for Patients With Pretreated Metastatic Colorectal Cancer
• FDA Approves Repotrectinib for Adults With Advanced/Metastatic ROS1+ NSCLC
• Pembrolizumab Is Approved for Patients With HER2– Gastric/GEJ Adenocarcinoma
• FDA Approves Capivasertib/Fulvestrant for Advanced/Metastatic, HR+, HER2- Breast Cancer
• FDA Approves Enzalutamide for High-Risk Nonmetastatic Castration-Sensitive Prostate Cancer
• FDA OKs Nirogacestat for Adults Patients With Desmoid Tumors

December

• FDA Grants Pirtobrutinib Accelerated Approval to Treat CLL/SLL in the Third Line
• FDA Approves Eflornithine for Children, Adults With High-Risk Neuroblastoma
• FDA Approves Belzutifan for Patients With Advanced Renal Cell Carcinoma
• Enfortumab Vedotin Plus Pembrolizumab Snags Full Approval for Patients With Locally Advanced or Metastatic Urothelial Cancer