FDA and EMA Oncology Drug Approvals in Q2 2026 Included Several New Options for Breast Cancer Treatment

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved 32 new or expanded indications for previously approved agents, including 5 new oncology agents, in the second quarter (Q2)of 2026. The approvals included approximately 24 solid tumor types and 8 hematologic malignancies. Two-thirds of the approvals were for biologics or biosimilars; there were 3 biosimilar and 17 biologic approvals. Three drugs were approved by both the FDA and the EMA: datopotamab deruxtecan (Datroway®; Daiichi Sankyo and AstraZeneca) and sacituzumab govitecan (Trodelvy®; Gilead) for treatment of triple-negative breast cancer, and decitabine and cedazuridine (Inqovi® in the US and Inaqovi® in the EU; Otsuka) in combination with venetoclax for treatment of acute myeloid leukemia.

Additional highlights from the Q2 2026

• Drug approvals encompassed 16 different modes of action/targets; the most common were checkpoint inhibitors (8 approvals) and 6 antibody-drug conjugates
• One-third of the approvals were treatments for breast cancer, encompassing different subtypes and stages
• There were 5 new agents approved
  • Clinically known as Orca-T®, allogeneic regulatory T cell immunotherapy with hematopoietic stem and progenitor cells (HSPC) and T cells-vldq (Tregzi™) became the first FDA-approved precision-engineered cell therapy for allogeneic transplant in adults with hematologic malignancies
  • Camizestrant (Etcamah; AstraZeneca) received positive opinion from the EMA for treatment of estrogen receptor 1 (ESR1)-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, while the FDA has requested additional data and extended the Prescription Drug User Fee Act date for approval of this agent in the US 
  • The FDA approved the first antibody-drug conjugate initiated in an outpatient setting for blastic plasmacytoid dendritic cell neoplasm, pivekimab sunirine-pvzy (Decnupaz™; AbbVie)
    • This was also the first antibody-drug conjugate approved by the FDA for blood cancer 
  • Sonrotoclax (Beqalzi; BeOne Medicines) received accelerated approval by the FDA for treatment of mantle cell lymphoma (MCL) 
    • Sonrotoclax is the first new B-cell lymphoma 2 (BCL2) inhibitor approved in the US in 10 years and the only BCL2 inhibitor approved in MCL 
  • The FDA approved vepdegestrant (Veppanu™; Arvinas), a proteolysis targeting chimera (PROTAC)—a type of heterobifunctional protein degrader therapy—for treatment of estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer 
• The FDA also approved 5 companion devices 
  • The Signatera CDx (Natera, Inc) to select patients with muscle-invasive bladder cancer after cystectomy who have circulating tumor DNA minimal/measurable residual disease for adjuvant treatment with atezolizumab (Tecentriq®; Genentech) or with atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza®; Genentech)
  • The Ventana PTEN (SP218) RxDx Assay (Ventana Medical Systems, Inc/Roche Diagnostics) to identify patients with phosphatase and tensin homolog (PTEN)-deficient prostate cancer for treatment with capivasertib (Truqap®; AstraZeneca) 
  • The PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody for identifying HER2-positive (immunohistochemistry [IHC] 3+ or in situ hybridization [ISH]+) patients for treatment with trastuzumab deruxtecan (T-DXd) 
  • The VENTANA HER2 Dual ISH DNA Probe Cocktail for identifying HER2-positive (IHC 3+ or ISH+) patients for treatment with T-DXd 
  • The Guardant360 CDx as a companion diagnostic device to identify patients with breast cancer with ESR1 mutations for treatment with vepdegestrant 
• Karyopharm Therapeutics, manufacturer of selinexor (Xpovio®), voluntarily withdrew the indication for third-line treatment of diffuse large B-cell lymphoma 
  • The drug had previously received accelerated approval for this indication, but the phase III confirmatory trial was not conducted
  • Selinexor is still approved for treatment of multiple myeloma
     

The tables below summarize key oncology approvals in Q2 2026. Treatments in bold font represent new–agent approvals; all others are biosimilars, indication expansions, or converted from accelerated to full approval (FDA). 

FDA and EMA Approvals 

aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.  

bBiologic. 

cBiosimilar.  

dAccelerated approval. 

AKT, serine/threonine protein kinase; AML, acute myeloid leukemia; BCL2, B-cell lymphoma 2; BPDCN, blastic plasmacytoid dendritic cell neoplasm; BTK, Bruton tyrosine kinase inhibitor; ccRCC, clear-cell renal cell carcinoma; CDK4/6, cyclin-dependent kinases 4 and 6; CLL, chronic lymphocytic leukemia; EMA, European Medicines Agency; FDA, US Food and Drug Administration; G-CSF, granulocyte colony-stimulating factor; HSPC, hematopoietic stem and progenitor cells; MCL, mantle cell lymphoma; MOA, mechanism of action; PD-1, programmed cell death protein 1; PD-L1, PD-1 ligand 1; RANKL, receptor activator of nuclear factor Kappa-B ligand; SERD, selective estrogen receptor degrader.

Sources: 

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process 

https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications 

https://www.ema.europa.eu/en/committees/chmp/chmp-agendas-minutes-highlights 

https://ir.arvinas.com/news-releases/news-release-details/arvinas-announces-fda-approval-veppanu-vepdegestrant-treatment 

https://ir.beonemedicines.com/news/beone-medicines-beqalzitm-sonrotoclax-approved-by-us-fda-as-first-and-only-bcl2-inhibitor-for/a57256f1-5e36-427a-94c3-2b6be7f2bfb9 

https://news.abbvie.com/2026-05-27-U-S-FDA-Approves-DECNUPAZTM-pivekimab-sunirine-pvzy-for-Treatment-of-Adult-Patients-with-Blastic-Plasmacytoid-Dendritic-Cell-Neoplasm,-an-Ultra-Rare-and-Aggressive-Blood-Cancer-With-Limited-Treatment-Options 

https://orcabio.com/orca-bios-tregzi-receives-u-s-fda-approval-as-first-and-only-precision-engineered-cell-therapy-for-allogeneic-transplant-in-adults-with-hematological-malignanciesorca-bio-adds-east/ 

https://www.asco.org/news-initiatives/policy-news-analysis/fda-withdraws-accelerated-approval-xpovio-dlbcl