The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved 37 new or expanded indications for previously approved agents and only 1 new oncology agent in the first quarter (Q1) of 2026. The approvals included approximately 18 solid tumor types and 6 hematologic malignancies. Half of the approvals were for biologics or biosimilars; there were 2 biosimilar and 17 biologic approvals. There was 1 drug approval by both the FDA and the EMA for an extended indication: nivolumab (Opdivo®; Bristol Myers Squibb) for treatment of Hodgkin lymphoma. One new agent was approved by the FDA for treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer: relacorilant (Lifyorli™), a glucocorticoid receptor antagonist manufactured by Corcept Therapeutics.
Additional highlights from the first quarter of 2026
- Drug approvals encompassed 21 different modes of action; the most common were programmed cell death protein 1 (PD-1) inhibitors (9 approvals), v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) inhibitors (4 approvals), and bispecifics (3 approvals)
- The tumor types with the most approvals were Hodgkin lymphoma (4); ovarian, fallopian tube, and primary peritoneal (3, plus 1 additional approval for ovarian cancer); lung (5; non-small cell lung cancer [NSCLC] and small cell lung cancer [SCLC]); chronic lymphocytic leukemia (3); and multiple myeloma (3)
- Four approvals were for nivolumab (Opdivo; Bristol Myers Squibb), 3 by the FDA and 1 by the EMA, all for different types of Hodgkin lymphoma
- One product, zongertinib (Hernexeos®; Boehringer Ingelheim), received accelerated approval by the FDA for treatment of advanced, previously treated human epidermal growth factor receptor 2 (HER2)-mutant non-squamous NSCLC
- FDA conversions from accelerated to traditional approvals included
- Encorafenib (Braftovi®; Pfizer) for treatment of colorectal cancer with a BRAF V600E mutation, an indication expansion to fluorouracil-based chemotherapy regimens
- Nivolumab (Opdivo; Bristol Myers Squibb) for treatment of relapsed or refractory Hodgkin lymphoma after homologous stem cell transplantation (HSCT) and brentuximab vedotin
- Nivolumab (Opdivo; Bristol Myers Squibb) for treatment of relapsed or refractory Hodgkin lymphoma after 3 or more lines of systemic therapy that includes HSCT
- Teclistamab-cqyv (Tecvayli®; Johnson & Johnson) for treatment of relapsed or refractory multiple myeloma after 4+ lines of therapy
- The FDA also approved the PD-L1 IHC 22C3 pharmDx (Agilent Technologies, Inc) as a companion diagnostic device to identify patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-1 ligand 1 (PD-L1; Combined Positive Score ≥1) for treatment with pembrolizumab (Keytruda®; Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex™), both manufactured by Merck
- The EMA approved (positive opinion) retifanlimab-dlwr (Zynyz®; Incyte Biosciences), the first treatment specifically authorized in the EU for treatment of adults with squamous cell carcinoma of the anal canal (SCAC), the most common type of anal cancer, which composes about 85% of cases
The tables below summarize key oncology approvals in Q1 2026. Treatments in bold font represent new-agent approvals; all others are biosimilars, indication expansions, or conversion from accelerated to full approval (FDA).
FDA and EMA Approvals | |||||
Generic Name | Brand Name | Tumor Typea | MOA | Manufacturer | Approval |
Nivolumabb | Opdivo | Hodgkin lymphoma | PD-1–blocking antibody | Bristol Myers Squibb | 3/20/26 (FDA) / January 2026 (EMA) |
FDA Approvals | |||||
Generic Name | Brand Name | Tumor Typea | MOA/Drug Class | Manufacturer | Approval |
Acalabrutinib | Calquence® (capsules) | CLL, SLL | BTK inhibitor | AstraZeneca | 2/19/26 |
Acalabrutinib maleate | Calquence (tablets) | CLL, SLL | BTK inhibitor | AstraZeneca | 2/19/26 |
Daratumumab and hyaluronidase-fihjb | Darzalex Faspro® | Multiple myeloma | Monoclonal antibody and polysaccharide | Johnson & Johnson | 1/27/26 |
Encorafenib | Braftovi | Colorectal | BRAF V600E inhibitor | Pfizer | 2/24/26 |
Etoposide | Avopef | Testicular, SCLC | Topoisomerase II inhibitor | Avyxa Holdings | 1/15/26 |
Filgrastim-lahac | Filkri™ | Neutropenia | G-CSF | Accord BioPharma | 1/15/26 |
Leucovorin calcium | Vykoura™ | Colorectal | Folate analogue | Avyxa Holdings | 2/3/26 |
Nivolumabb | Opdivo | Hodgkin lymphoma (R/R, after HSCT and brentuximab vedotin) | PD-1–blocking antibody | Bristol Myers Squibb | 3/20/26 |
Nivolumabb | Opdivo | Hodgkin lymphoma (R/R, after 3+ lines of systemic therapy that includes HSCT) | PD-1–blocking antibody | Bristol Myers Squibb | 3/20/26 |
Pembrolizumabb | Keytruda | Epithelial ovarian, fallopian tube, or primary peritoneal carcinoma | PD-1 inhibitor | Merck | 2/10/26 |
Pembrolizumab and berahyaluronidase alfa-pmphb | Keytruda Qlex | Epithelial ovarian, fallopian tube, or primary peritoneal carcinoma | PD-1 inhibitor and endoglycosidase | Merck | 2/10/26 |
Relacorilant | Lifyorli | Epithelial ovarian, fallopian tube, or primary peritoneal carcinoma | Glucocorticoid receptor antagonist | Corcept | 3/25/26 |
Teclistamab-cqyvb | Tecvayli® | Multiple myeloma (R/R after 4+ lines of therapy) | Bispecific | Johnson & Johnson | 3/5/26 |
Teclistamab-cqyvb | Tecvayli | Multiple myeloma (2L) | Bispecific | Johnson & Johnson | 3/5/26 |
Venetoclax | Venclexta® | CLL | BCL2 inhibitor | AbbVie | 2/19/26 |
Zongertinib | Hernexeos | NSCLC | HER2 inhibitor | Boehringer Ingelheim | 2/26/26d |
EMA Approvals | |||||
Generic Name | Brand Name | Tumor Typea | MOA/Drug Class | Manufacturer | Positive Opinion |
Asciminib | Scemblix® | Ph+ CML | TKI | Novartis | February 2026 |
Dabrafenib | Tafinlar® | Melanoma | BRAF inhibitor | Novartis | March 2026 |
Dabrafenib | Tafinlar | Thyroid | BRAF inhibitor | Novartis | March 2026 |
Durvalumabb | Imfinzi® | Gastric/GEJ | PD-L1–blocking antibody | AstraZeneca | January 2026 |
Inotuzumab ozogamicinb | Besponsa® | Pediatric ALL | Antibody-drug conjugate | Pfizer | March 2026 |
Lurbinectedin | Zepzelca® | SCLC | Alkylating agent | Pharmamar | March 2026 |
Lutetium (177Lu) chloride | Ilumira | Radiolabeling of carrier molecules | Radiopharmaceutical precursor | SHINE Europe | January 2026 |
Nadofaragene firadenovec-vncgb | Adstiladrin® | Bladder | Non-replicating adenoviral vector-based gene therapy | Ferring Pharmaceuticals | March 2026 |
Niraparib/abiraterone acetate | Akeega® | Prostate | PARP inhibitor and CYP17 inhibitor | Janssen Biotech | January 2026 |
Pembrolizumabb | Keytruda | Ovarian | PD-1 inhibitor | Merck Sharp & Dohme | February 2026 |
Pertuzumab-dpzbc | Poherdy® | Breast | HER2/neu receptor antagonist | Organon | February 2026 |
Ponatinib | Iclusig® | Ph+ ALL | TKI | Incyte | January 2026 |
Retifanlimabb | Zynyz | SCAC | PD-1 inhibitor | Incyte | January 2026 |
Selpercatinib | Retevmo® | Solid tumors | RET inhibitor | Eli Lilly | March 2026 |
Serplulimabb | Hetronifly® | Esophageal SCC | PD-1 inhibitor | Accord Healthcare | March 2026 |
Serplulimabb | Hetronifly | NSCLC | PD-1 inhibitor | Accord Healthcare | March 2026 |
Tarlatamab-dlleb | Imdelltra® | SCLC | Bispecific antibody | Amgen | March 2026 |
Tovorafenib | Ojemda™ | Low-grade glioma | BRAF inhibitor | Ipsen | February 2026 |
Trametinib | Mekinist® | Melanoma (age 12+) | MEK inhibitor | Novartis | March 2026 |
Trametinib | Mekinist | Thyroid | MEK inhibitor | Novartis | March 2026 |
aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.bBiologic.cBiosimilar.dAccelerated approval.2L, second line; ALL, acute lymphoblastic leukemia; BCL2, B-cell lymphoma 2; BRAF, v-Raf murine sarcoma viral oncogene homolog B1; BTK, Bruton tyrosine kinase inhibitor; CLL, chronic lymphocytic leukemia; CML, chronic myeloid leukemia; CYP17, cytochrome P450 family 17; EMA, European Medicines Agency; FDA, US Food and Drug Administration; G-CSF, granulocyte colony-stimulating factor; GEJ, gastroesophageal junction; HER2, human epidermal growth factor receptor 2; HSCT, hematopoietic stem cell transplantation; MEK, mitogen-activated protein kinase; MOA, mechanism of action; NSCLC, non-small cell lung cancer; PARP, poly(ADP-ribose) polymerase; PD-1, programmed cell death protein 1; PD-L1, PD-1 ligand 1; Ph+, Philadelphia chromosome-positive; RET, rearranged during transfection; R/R, relapsed/refractory; SCAC, squamous cell carcinoma of the anal canal; SCC, squamous cell carcinoma; SCLC, small cell lung cancer; SLL, small lymphocytic lymphoma; TKI, tyrosine kinase inhibitor. | |||||
Sources:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process
