FDA Oncology Approvals in 2022: Timeline of Novel Treatment Options
The past year has been filled with new and exciting improvements and novel treatment options in the field of oncology and hematology. The FDA has granted approval and accelerated approval to many new drugs and drug combinations, including the very first approval for patients with HER2-mutant non–small cell lung cancer, trastuzumab deruxtecan. This is a great time to reflect on the current treatment landscape and ponder what 2023 could have in store for future approvals and emerging treatment options for your patients.
2022 Approval Timeline
January
Tebentafusp-Tebn for Uveal Melanoma
March
Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma
Pacritinib for Intermediate- or High-Risk Myelofibrosis With Thrombocytopenia
Nivolumab as Neoadjuvant Therapy for Resectable Non–Small Cell Lung Cancer
Olaparib as Adjuvant Treatment for BRCA-Mutated High-Risk Early Breast Cancer
Combination of Nivolumab and Relatlimab for Unresectable or Metastatic Melanoma
Pembrolizumab for Advanced Endometrial Carcinoma
Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer
April
Axicabtagene Ciloleucel for Second-Line Treatment of Large B-Cell Lymphoma
May
Fam-Trastuzumab Deruxtecan-nxki for Breast Cancer
Azacitidine for Pediatric Patients with Newly Diagnosed Myelomonocytic Leukemia
Ivosidenib in Combination With Azacitidine for Acute Myeloid Leukemia
June
Accelerated Approval of Tisagenlecleucel for Relapsed or Refractory Follicular Lymphoma
Nivolumab Plus Fluoropyrimidine and Platinum-Based Chemotherapy and Nivolumab Plus Ipilimumab for Esophageal Squamous Cell Carcinoma
Umbralisib Withdrawn for Marginal Zone Lymphoma and Follicular Lymphoma
Dabrafenib Plus Trametinib for Unresectable or Metastatic BRAF V600E Mutations
Lisocabtagene Maraleucel for Relapsed/Refractory Large B-Cell Lymphoma
July
Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumors
August
Trastuzumab Deruxtecan for HER2-Low Breast Cancer
Darolutamide for Metastatic Hormone-Sensitive Prostate Cancer
Capmatinib for Metastatic Non–Small Cell Lung Cancer
Trastuzumab Deruxtecan: First Approval for HER2-Mutant Non–Small Cell Lung Cancer
Ibrutinib for Pediatric Patients With Chronic Graft-Versus-Host Disease
Pemigatinib for Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement
September
Durvalumab for Biliary Tract Cancer
Selpercatinib for RET Fusion–Positive Non–Small Cell Lung Cancer
Selpercatinib for RET Fusion–Positive Solid Tumors
October
Accelerated Approval of Futibatinib for Cholangiocarcinoma
Tremelimumab Plus Durvalumab for Unresectable Hepatocellular Carcinoma
Accelerated Approval of Teclistamab for Relapsed/Refractory Multiple Myeloma
November
Cemiplimab-rwlc for Non–Small Cell Lung Cancer
Tremelimumab Plus Durvalumab and Platinum-Based Chemotherapy for Metastatic NSCLC
Mirvetuximab Soravtansine for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancers
December
Olutasidenib for Acute Myeloid Leukemia
Atezolizumab for Alveolar Soft Part Sarcoma
Adagrasib for KRAS G12C–Mutated Non–Small Cell Lung Cancer
Nadofaragene Firadenovec-vncg for Non–Muscle-Invasive Bladder Cancer
Pafolacianine for Detection of Lung Cancer Lesions
Mosunetuzumab-axgb for Relapsed/Refractory Follicular Lymphoma
