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


Tebentafusp-Tebn for Uveal Melanoma


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


Axicabtagene Ciloleucel for Second-Line Treatment of Large B-Cell Lymphoma


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


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Umbralisib Withdrawn for Marginal Zone Lymphoma and Follicular Lymphoma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


Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumors


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


Durvalumab for Biliary Tract Cancer

Selpercatinib for RET Fusion–Positive Non–Small Cell Lung Cancer

Selpercatinib for RET Fusion–Positive Solid Tumors


Accelerated Approval of Futibatinib for Cholangiocarcinoma

Tremelimumab Plus Durvalumab for Unresectable Hepatocellular Carcinoma

Accelerated Approval of Teclistamab for Relapsed/Refractory Multiple Myeloma


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


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

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