FDA Oncology Approvals

A year-by-year index of FDA oncology and hematology drug approvals.

• FDA Approves SimpleScreen CRC — A Blood-Based Colorectal Cancer Screening Test for Average-Risk Adults
• FDA Grants Priority Review to Talazoparib Plus Enzalutamide for HRR-Mutated Metastatic Castration-Sensitive Prostate Cancer
• FDA Approves Zidesamtinib (Jideytro) for Pretreated ROS1-Positive NSCLC
• FDA Approves Gedatolisib (Revtorpyk) for HR+/HER2-, PIK3CA Wild-Type Advanced Breast Cancer
• FDA Approves Vimseltinib (Romvimza) for Symptomatic Tenosynovial Giant Cell Tumor
• FDA Approves Penpulimab-kcqx for Recurrent or Metastatic Nasopharyngeal Carcinoma — First Approval Dedicated to NPC
• FDA Approves Cosibelimab-ipdl (Unloxcyt) for Advanced Cutaneous Squamous Cell Carcinoma — First PD-L1 Antibody in cSCC
• FDA Approves Revumenib (Revuforj) for Relapsed or Refractory KMT2A-Translocated Acute Leukemia — First Menin Inhibitor
• FDA Approves Lazertinib (Lazcluze) With Amivantamab for First-Line EGFR-Mutated Advanced NSCLC — MARIPOSA
• FDA Grants Accelerated Approval to Sonrotoclax (Beqalzi) for Relapsed/Refractory Mantle Cell Lymphoma After a BTK Inhibitor
• FDA Approves Relacorilant (Lifyorli) With Nab-Paclitaxel for Platinum-Resistant Ovarian Cancer
• FDA Approves Taletrectinib (Ibtrozi) for Locally Advanced or Metastatic ROS1-Positive Non–Small Cell Lung Cancer
• FDA Grants Accelerated Approval to Sunvozertinib (Zegfrovy) — First Oral EGFR Exon 20 Insertion TKI for NSCLC
• FDA Approves Treosulfan (Grafapex) With Fludarabine as an alloHSCT Conditioning Regimen for AML and MDS
• FDA Approves Vepdegestrant (Veppanu) — First PROTAC Protein Degrader — for ESR1-Mutated ER+/HER2− Advanced Breast Cancer
• FDA Grants Accelerated Approval to Sevabertinib (Hyrnuo) for Previously Treated HER2-Mutant Non–Small Cell Lung Cancer
• FDA Approves Ziftomenib (Komzifti) — First Menin Inhibitor — for Relapsed/Refractory NPM1-Mutated AML
• FDA Grants Accelerated Approval to Zongertinib (Hernexeos) for HER2 TKD-Mutant Non–Small Cell Lung Cancer
• FDA Grants Accelerated Approval to Dordaviprone (Modeyso) — First Therapy for H3 K27M-Mutant Diffuse Midline Glioma
• FDA Grants Accelerated Approval to Avutometinib + Defactinib (Avmapki Fakzynja Co-Pack) for KRAS-Mutant Recurrent Low-Grade Serous Ovarian Cancer
• FDA Approves Gedatolisib (Revtorpyk) With Fulvestrant ± Palbociclib for PIK3CA-Wild-Type HR+/HER2− Advanced Breast Cancer — VIKTORIA-1
• FDA Approves Palbociclib + Trastuzumab (± Pertuzumab) + Endocrine Therapy for HR+/HER2+ Metastatic Breast Cancer Maintenance — PATINA Trial
• FDA Expands PADCEV + Keytruda to All Muscle-Invasive Bladder Cancer Patients — EV-304 Trial Removes Cisplatin Eligibility Barrier
• FDA Approves Trodelvy as First-Line Therapy for Metastatic Triple-Negative Breast Cancer — First ADC Approved in Front-Line TNBC
• FDA Approves Isatuximab (Sarclisa Escena) Subcutaneous via On-Body Injector — First Anticancer Drug With Wearable Delivery Device for Multiple Myeloma
• FDA Approves Tregzi — First Allogeneic Regulatory T Cell Therapy — to Prevent Chronic GVHD After Stem Cell Transplant
• FDA Approves Belzutifan + Pembrolizumab for Adjuvant Clear Cell RCC — First PD-1 + HIF-2α Inhibitor Combination
• FDA Approves Oral INQOVI + Venetoclax for Newly Diagnosed AML — First All-Oral Combination for Transplant-Ineligible Patients
• FDA Approves Zenocutuzumab (Bizengri) for NRG1 Fusion-Positive Cholangiocarcinoma — First Therapy Targeting NRG1 Fusions in Bile Duct Cancer
• Zanidatamab + Chemotherapy Approved for HER2-Amplified Biliary Tract Cancer — First HER2-Targeted Approval in BTC
• FDA Approves Pivekimab Sunirine (DECNUPAZ) for Blastic Plasmacytoid Dendritic Cell Neoplasm — First Dedicated BPDCN Therapy Since 2018
• FDA Approves Venetoclax + Acalabrutinib — First All-Oral, Fixed-Duration Frontline Regimen for CLL/SLL
• FDA Approves Enfortumab Vedotin + Pembrolizumab as Perioperative Therapy for Muscle-Invasive Bladder Cancer — First Approval Regardless of Cisplatin Eligibility
• FDA Approves Imlunestrant (Inluriyo) for ESR1-Mutated HR+/HER2− Advanced Breast Cancer — Second Oral SERD Approved, First With CDK4/6 Inhibitor Combination Data
• Dato-DXd FDA-Approved for HR+/HER2− Metastatic Breast Cancer After Endocrine Therapy and Chemotherapy
• Patritumab Deruxtecan (HER3-DXd) FDA-Approved for EGFR-Mutated NSCLC After Osimertinib Progression
• KEYNOTE-522: Neoadjuvant Pembrolizumab + Chemotherapy Achieves 64.8% pCR in Early Triple-Negative Breast Cancer
• FDA Approves Inavolisib (Itovebi) for PIK3CA-Mutated HR+/HER2− Metastatic Breast Cancer — First PI3Kα Degrader-Inhibitor Approved in Oncology
• Perioperative Nivolumab Added to Chemoradiation Improves PFS in Locally Advanced Cervical Cancer
• IDH1/2 Inhibitor Vorasidenib Approved for Grade 2 IDH-Mutant Glioma
• Tisotumab Vedotin Demonstrates Overall Survival Benefit in Second-Line Cervical Cancer
• T-DXd Receives FDA Approval for HR+/HER2-Low Breast Cancer in First-Line Metastatic Setting
• Lifileucel — First TIL Therapy Approved — FDA Grants Accelerated Approval for Unresectable or Metastatic Melanoma
• Imetelstat — First Telomerase Inhibitor — FDA-Approved for Transfusion-Dependent Low-Risk MDS
• Repotrectinib FDA-Approved for ROS1-Positive NSCLC and NTRK Fusion-Positive Solid Tumors
• Tarlatamab — DLL3×CD3 Bispecific Antibody — Achieves 40% Response Rate in Relapsed SCLC
• FDA Approves First Personalized mRNA Cancer Vaccine — mRNA-4157 + Pembrolizumab for High-Risk Melanoma
• Mirvetuximab Soravtansine Achieves Confirmed OS Benefit in FRα-High Platinum-Resistant Ovarian Cancer
• Glofitamab Fixed-Duration CD20×CD3 Bispecific Approved for Relapsed/Refractory DLBCL
• Pembrolizumab + Chemotherapy Demonstrates OS Benefit in Advanced Endometrial Cancer — RUBY and NRG-GY018
• Pirtobrutinib — First Non-Covalent BTK Inhibitor — Approved for Mantle Cell Lymphoma After Prior BTK Inhibitor
• Adagrasib FDA-Approved for KRAS G12C-Mutated NSCLC — Second KRAS G12C Inhibitor Reaches Market
• Asciminib — First STAMP Inhibitor — Achieves Superior MMR in CML After 2+ Prior TKIs — ASCEMBL Trial Update
• Elacestrant FDA-Approved — First Oral SERD for ESR1-Mutated HR+/HER2− Metastatic Breast Cancer
• Futibatinib Approved for FGFR2-Fusion+ Cholangiocarcinoma — Covalent FGFR Inhibitor Overcomes Acquired Resistance
• T-DXd Transforms HER2-Low Breast Cancer — DESTINY-Breast04 Redefines a Previously Non-Targetable Population
• Olaparib + Abiraterone Improves rPFS in HRR-Mutated and Unselected mCRPC — PROpel Trial
• CheckMate-816: Neoadjuvant Nivolumab + Chemotherapy Doubles pCR Rate in Resectable NSCLC
• Pacritinib Approved for Myelofibrosis with Severe Thrombocytopenia — Addresses Critical Gap
• Pembrolizumab + Chemo ± Bevacizumab Approved as First-Line Standard for Persistent/Recurrent/Metastatic Cervical Cancer
• Pralsetinib Approved for RET-Fusion+ NSCLC and RET-Mutant Medullary Thyroid Cancer
• OlympiA Trial: Adjuvant Olaparib Reduces Recurrence Risk by 42% in BRCA1/2-Mutated Early Breast Cancer
• Loncastuximab Tesirine Approved for Relapsed/Refractory DLBCL — CD19-Directed ADC
• Olaparib Maintenance Improves OS in BRCA-Mutated Platinum-Sensitive Ovarian Cancer — SOLO2 and STUDY 19 Confirm Survival Benefit
• Idecabtagene Vicleucel (ide-cel) First BCMA CAR-T Approved for Triple-Class Refractory Multiple Myeloma
• T-DXd Approved for HER2-Positive Gastric Cancer — DESTINY-Gastric01 Demonstrates Survival Benefit
• Selpercatinib FDA-Approved for RET-Mutant Medullary Thyroid Cancer and RET Fusion-Positive Solid Tumors
• VIALE-A Trial: Venetoclax + Azacitidine Doubles OS vs. Azacitidine in Older Unfit AML
• FDA Approves Pembrolizumab for Tumor Mutational Burden-High Solid Tumors — Second Tissue-Agnostic Indication
• Brexucabtagene Autoleucel — First CAR-T Approved for Mantle Cell Lymphoma
• IMbrave150: Atezolizumab + Bevacizumab Outperforms Sorafenib in Advanced Hepatocellular Carcinoma
• Sacituzumab Govitecan Approved for Metastatic Triple-Negative Breast Cancer — First TROP2-Directed ADC
• Olaparib Approved for BRCA/HRR-Mutated mCRPC — PROfound Trial Demonstrates First PARP Inhibitor Activity in Prostate Cancer
• FDA Grants First Tissue-Agnostic Approval in History — Pembrolizumab for Any dMMR/MSI-H Solid Tumor
• CLL14: Fixed-Duration Venetoclax + Obinutuzumab Achieves Unprecedented uMRD Rates in Treatment-Naive CLL
• Isatuximab (Anti-CD38) + Pomalidomide + Dexamethasone Approved for Relapsed/Refractory Multiple Myeloma
• Larotrectinib — First Tissue-Agnostic TRK Inhibitor — FDA-Approved for Any NTRK Fusion-Positive Solid Tumor
• IMpassion130: Atezolizumab + Nab-Paclitaxel First Immunotherapy Regimen Active in Metastatic TNBC
• KEYNOTE-189: Pembrolizumab + Platinum-Pemetrexed Becomes First-Line Standard for Non-Squamous NSCLC Regardless of PD-L1
• CAR-T Cell Therapy Era Begins — Tisagenlecleucel and Axicabtagene Ciloleucel First Approvals