FDA oncology approvals are a real-time industry signal for new modalities, targets, and post-resistance therapy fronts. Since April 2026, Morning Glory Sciences has covered FDA oncology approvals comprehensively under a “one approval, one article” principle. This hub consolidates the major FDA oncology approvals from April–May 2026 — 10 key approvals + related — reorganized by (1) indication, (2) modality, and (3) strategic question. Use it for immediate reference to the latest approvals, comparison with past approvals, and competitive or investment analysis.
What This Hub Covers
- Complete map of 10 FDA oncology approvals in April–May 2026
- By indication: breast / hematologic / NSCLC / bladder / cholangiocarcinoma / BPDCN, etc.
- By modality: ADC, CAR-T, PROTAC, checkpoint inhibitor, oral agent, CD123 ADC
- Clinical significance and industry strategy (platform expansion, competitive maps)
- Direct links to each article plus indication-based navigation
Archive by Indication (April–May 2026)
Breast Cancer
- 2026-05-22: Datopotamab Deruxtecan-dlnk (Datroway, Daiichi Sankyo/AstraZeneca) — 1L mTNBC (PD-(L)1 ineligible), first TROP2 ADC in 1L, TROPION-Breast02
- 2026-05-21: Trastuzumab Deruxtecan (Enhertu, Daiichi Sankyo/AstraZeneca) — HER2-positive early breast cancer (neoadjuvant + adjuvant), DESTINY-Breast05/-Breast11
- 2026-05-21: Vepdegestrant (VEPPANU, Arvinas/Pfizer/Rigel) — ESR1-mutant ER+/HER2- advanced/metastatic breast cancer, world’s first PROTAC approval
Hematologic Cancers (CAR-T / ADC / Combination)
- 2026-05-27: Pivekimab Sunirine-pvzy (Decnupaz, AbbVie) — BPDCN (adult), CD123 ADC, CADENZA, first new BPDCN approval in 8 years since tagraxofusp
- 2026-05-21: Brexucabtagene Autoleucel (Tecartus, Kite/Gilead) — Relapsed/refractory mantle cell lymphoma
- 2026-05-21: Sonrotoclax (Beqalzi, BeOne Medicines) — Relapsed/refractory mantle cell lymphoma, BCL2 inhibitor
- 2026-05-21: Oral Decitabine + Cedazuridine (Inqovi, Taiho Oncology) + Venetoclax — Newly diagnosed AML unfit for intensive induction
Bladder / Urothelial
- 2026-05-28: Durvalumab (Imfinzi, AstraZeneca) + BCG — BCG-naïve high-risk non-muscle invasive bladder cancer, POTOMAC, first immunotherapy combination in NMIBC
- 2026-05-21: Atezolizumab (Tecentriq, Genentech/Roche) — Muscle-invasive bladder cancer adjuvant in MRD-positive patients
Cholangiocarcinoma
- 2026-05-21: Zenocutuzumab-zbco (Bizengri, Merus N.V.) — NRG1 fusion-positive advanced cholangiocarcinoma, HER2/HER3 bispecific antibody
By Modality — 2026 Strategic Questions
- ADC (Antibody-Drug Conjugates): Daiichi Sankyo/AstraZeneca’s DXd platform (T-DXd, Dato-DXd) won early breast cancer and 1L mTNBC in the same month; AbbVie’s CD123 ADC (Decnupaz) enters hematology. ADCs in 2026 expand into early-stage disease, rare diseases, and non-traditional targets
- CAR-T / Cell Therapy: Tecartus (autologous CAR-T) received a booster approval in R/R MCL; the In Vivo CAR-T frontier advances in parallel (see our In Vivo CAR-T Revolution series)
- PROTAC (Targeted Degraders): Arvinas’ VEPPANU is the world’s first PROTAC approval — a landmark. Expansion to KRAS and other targets is expected
- Immunotherapy Combinations: Imfinzi + BCG is the first immunotherapy combo in NMIBC. Checkpoint inhibitors are accelerating expansion into early-stage disease and adjuvant therapy
Cross-Cluster Series
- KRAS Frontier series — sotorasib/adagrasib, daraxonrasib/zoldonrasib, and the next-generation landscape of KRAS inhibitors
- In Vivo CAR-T Revolution series — Lilly, AbbVie, and the redefinition of gene therapy by major players
- Nuclear Medicine Frontier series — Pluvicto, Lutathera, and the radiopharmaceutical competitive structure
- AI Drug Discovery: Two Layers series — operational transformation behind AI-driven drug discovery reaching FDA approval
Strategic Perspective / My Thoughts
FDA oncology approvals in April–May 2026 consolidate four structural shifts: (1) ADC modality expansion into early-stage disease, (2) the world’s first PROTAC approval, (3) immunotherapy combination entering NMIBC, and (4) the second approved drug in BPDCN and other rare diseases. Tracking the picture by modality — rather than just by individual approval — reveals the 2027–2030 competitive landscape. This hub is structured for ongoing reference: not only for immediate consultation of the latest approvals but for comparison with past approvals, modality-level roadmap creation, and investment-decision input. Future FDA approvals will be added monthly.
※This hub is the consolidated index for Morning Glory Sciences’ FDA Oncology Approval Archive (April–May 2026). For each approval’s detailed data, trial design, safety, and strategic context, refer to the individual article. This hub will be updated as new approvals are added.
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