FDA hematology approvals 2022 to 2026

2022 Approvals

• Apr 1: axi-cel (Yescarta): 2L LBCL refractory to/relapse <12 months from 1L chemotherapy (ZUMA-7; NEJM 2021).
• Jun 24: liso-cel (Breyanzi): 2L LBCL refractory/relapse <12 mo from 1L (TRANSFORM; Lancet 2022).
• Oct 25: teclistamab (Tecvayli): 5L+ R/R MM (after ≥4 prior lines), BCMA×CD3 bispecific (MajesTEC-1; NEJM 2022).
• Dec 22: mosunetuzumab (Lunsumio): 3L+ FL, first CD20×CD3 bispecific (GO29781; Lancet Oncol 2022).
• Dec 1: olutasidenib (Rezlidhia): R/R IDH1-mutated AML (second IDH1 inhibitor, after ivosidenib).
• May 25: ivosidenib (Tibsovo) + azacitidine: newly diagnosed IDH1-mutated AML, age ≥75 or comorbidities precluding intensive induction (AGILE; NEJM 2022).
• Jan 25: tebentafusp (Kimmtrak): HLA-A*02:01+ unresectable/metastatic uveal melanoma (IMCgp100-202; NEJM 2021). Solid tumor, not heme.
• Dec 2022 (EU only): tabelecleucel (Ebvallo): EBV+ PTLD post-SOT/HSCT; approved in Europe, NOT FDA-approved (FDA complete response letters Jan 2025 and Jan 2026).

2023 Approvals

• Jan 19: zanubrutinib (Brukinsa): CLL/SLL, treatment-naive and R/R (SEQUOIA, ALPINE).
• Jan 27: pirtobrutinib (Jaypirca): R/R MCL after ≥2 lines including a BTKi (first approval, accelerated; BRUIN).
• May 19: epcoritamab (Epkinly): 3L+ R/R DLBCL, CD20×CD3 subcutaneous bispecific (EPCORE NHL-1; J Clin Oncol 2023).
• Jun 15: glofitamab (Columvi): 3L+ R/R DLBCL, CD20×CD3 IV bispecific, fixed-duration (NP30179; NEJM 2022).
• Aug 14: elranatamab (Elrexfio): 5L+ R/R MM, BCMA×CD3 bispecific (MagnetisMM-3; Nat Med 2023).
• Aug 9: talquetamab (Talvey): 5L+ R/R MM, GPRC5D×CD3 bispecific (MonumenTAL-1; NEJM 2022).
• Apr 19: polatuzumab vedotin (Polivy): 1L DLBCL with IPI ≥2; CD79b antibody-drug conjugate (POLARIX; NEJM 2022).
• Sep 8: motixafortide (Aphexda): CXCR4 antagonist + filgrastim for stem cell mobilization before auto-HSCT in multiple myeloma only (GENESIS; phase III).
• Jul 20: quizartinib (Vanflyta): newly diagnosed FLT3-ITD+ AML with chemotherapy (QuANTUM-First; Lancet 2023).
• Sep 15: momelotinib (Ojjaara): myelofibrosis with anemia (MOMENTUM, SIMPLIFY-1; phase III).
• Besremi (ropeginterferon alfa-2b): polycythemia vera approval dates to Nov 12, 2021 (no separate 2023 PV extended-use approval; see 2026 for essential thrombocythemia).
• Dec 1, 2023: pirtobrutinib (Jaypirca): R/R CLL/SLL after ≥2 lines incl. BTKi + BCL2i (accelerated; BRUIN); traditional approval Dec 3, 2025 for R/R CLL/SLL after a covalent BTKi.

2024 Approvals

• Oct 29: asciminib (Scemblix): 1L CML-CP (accelerated; ASC4FIRST; NEJM 2024).
• Apr 5: cilta-cel (Carvykti): R/R MM after ≥1 prior line incl. PI and IMiD, lenalidomide-refractory (CARTITUDE-4; earlier-line CAR-T vs ide-cel).
• Apr 4: ide-cel (Abecma): R/R MM after ≥2 prior lines incl. IMiD, PI, anti-CD38 (KarMMa-3; NEJM 2023).
• Mar 14: liso-cel (Breyanzi): R/R CLL/SLL after ≥2 prior lines incl. a BTKi and a BCL2i (accelerated; TRANSCEND CLL 004); first CAR-T for CLL.
• May 15: liso-cel (Breyanzi): R/R FL after ≥2 prior lines (accelerated; TRANSCEND FL).
• May 30: liso-cel (Breyanzi): R/R MCL post-≥2 prior lines incl. BTKi (TRANSCEND NHL 001 MCL cohort; J Clin Oncol 2024).
• Jun 2024: epcoritamab (Epkinly): 3L+ R/R FL (expanded indication from DLBCL).
• Jul 30: daratumumab SC + VRd (D-VRd): transplant-eligible NDMM, induction and consolidation (PERSEUS). (DRd for transplant-ineligible NDMM dates to 2019, MAIA.)
• Sep 20: isatuximab + bortezomib + lenalidomide + dex (IsaVRd): 1L transplant-ineligible NDMM (IMROZ; superior PFS vs VRd).
• Jun 6: imetelstat (Rytelo): low- to intermediate-1-risk MDS with transfusion-dependent anemia (≥4 RBC units/8 weeks), ESA relapsed/refractory or ineligible (IMerge; Lancet 2024).
• Nov 15: revumenib (Revuforj): R/R KMT2A-translocated acute leukemia, adults and children ≥1 yr, menin inhibitor (AUGMENT-101). Expanded Oct 24, 2025 to R/R NPM1-mutated AML.
• Dec 20, 2024 (accelerated): encorafenib + cetuximab + mFOLFOX6: BRAF V600E-mutant metastatic CRC 1L (BREAKWATER); traditional approval Feb 24, 2026. Solid tumor, not heme.

2025 Approvals

• Jan 16: sotorasib + panitumumab: KRAS G12C-mutant metastatic CRC after fluoropyrimidine, oxaliplatin, and irinotecan (CodeBreaK 300); not 1L, no mFOLFOX6. Solid tumor, not heme.
• Jun 23: datopotamab deruxtecan (Dato-DXd): previously treated EGFR-mutant advanced NSCLC after EGFR TKI and platinum chemotherapy (accelerated; TROPION-Lung05/Lung01). Solid tumor, not heme.
• May 14: telisotuzumab vedotin (Emrelis; c-Met-directed ADC): previously treated nonsquamous NSCLC with high c-Met protein overexpression (accelerated). Solid tumor, not heme.
• Aug 8: zongertinib (HER2 tyrosine kinase inhibitor): previously treated HER2 (ERBB2) TKD-mutant nonsquamous NSCLC (accelerated; Beamion LUNG-1). Solid tumor, not heme.
• Nov 13: ziftomenib (Komzifti; menin inhibitor): R/R NPM1-mutated AML only (KOMET-001); not approved for KMT2A-r leukemia.
• 2025 myeloma approvals: linvoseltamab (Lynozyfic; Jul 2; R/R MM after ≥4 lines, BCMA×CD3), belantamab mafodotin + bortezomib/dex (Blenrep; Oct 23; R/R MM after ≥2 lines; DREAMM-7), daratumumab SC for high-risk smoldering MM (Nov 6; AQUILA).

2026 Approvals

• Feb 26: zongertinib: HER2 TKD-mutant NSCLC, expanded accelerated approval including treatment-naive patients (Beamion LUNG-1). Solid tumor, not heme.
• Sep 9, 2026: sevabertinib (Hyrnuo; HER2 TKI): accelerated approval expanded to treatment-naive HER2 (ERBB2) TKD-mutant nonsquamous NSCLC (SOHO-01); initial accelerated approval Nov 19, 2025 was for previously treated disease. Solid tumor, not heme.
• Zipalertinib (EGFR exon 20 TKI): NOT approved; NDA accepted Apr 2026 for EGFR exon 20 insertion+ NSCLC after platinum (REZILIENT1), PDUFA Feb 27, 2027. Solid tumor, not heme.
• 2026 heme approvals: daratumumab SC + VRd for newly diagnosed MM (Jan 27; CEPHEUS), acalabrutinib + venetoclax for CLL/SLL (Feb 19; AMPLIFY), teclistamab + daratumumab SC for R/R MM after ≥1 line (Mar 5), oral decitabine/cedazuridine + venetoclax for unfit newly diagnosed AML (May 13), sonrotoclax for R/R MCL after ≥2 lines including a BTKi (May 13; accelerated), pivekimab sunirine for BPDCN (May 27), iberdomide + daratumumab SC + dex for R/R MM (Aug 13; accelerated), isatuximab SC formulation (Jul 9).
• Aug 31: ropeginterferon alfa-2b (Besremi): essential thrombocythemia (SURPASS-ET vs anagrelide); PV approval dates to 2021.
• Mar 20, 2026: nivolumab + AVD (Opdivo): stage III-IV classical HL 1L adults & ≥12 yo (FDA approval Mar 2026; SWOG S1826, NEJM 2024). Replaces brentuximab vedotin + AVD.

High-Yield Hematology Pearls 2022 to 2026

• Bispecific T-cell engagers (TCE) for B-NHL: mosunetuzumab (FL), epcoritamab (DLBCL/FL subcutaneous), glofitamab (DLBCL IV fixed-duration).
• BCMA-targeted MM: bispecifics (teclistamab, elranatamab; talquetamab is GPRC5D-targeted, not BCMA) and CAR-T (ide-cel, cilta-cel). CAR-T moved to earlier lines (cilta-cel after ≥1 prior line, ide-cel after ≥2); bispecific monotherapies (teclistamab, elranatamab, talquetamab) still require ≥4 prior lines (teclistamab + daratumumab combination now ≥1 line).
• CAR-T for B-NHL: axi-cel (ZUMA-7 2L DLBCL), liso-cel (2L LBCL, FL 3L+, MCL 3L+), brexu-cel (MCL 2L+).
• 1L AML: quizartinib (FLT3-ITD) + chemo, ivosidenib + azacitidine (IDH1-mut ineligible for intensive); menin inhibitors are approved only for R/R KMT2A-r or NPM1-mut disease.
• 1L CML-CP: asciminib (Scemblix) added to standard TKI armamentarium; ABL allosteric inhibitor.
• 1L classical HL: nivolumab + AVD replaces BV + AVD (S1826; NEJM 2024).
• R/R CLL: pirtobrutinib post-BTKi ± BCL2i (non-covalent BTKi); liso-cel (post-BTKi/BCL2i).
• Lower-risk MDS: imetelstat (first-in-class telomerase inhibitor; IMerge) for transfusion-dependent anemia after or ineligible for ESAs (luspatercept and lenalidomide for del(5q) were approved earlier).
• Menin inhibitors: revumenib (R/R KMT2A-r acute leukemia Nov 2024; R/R NPM1-mut AML Oct 2025), ziftomenib (R/R NPM1-mut AML Nov 2025).