FDA Approvals in Oncology: January-March 2026

In the first three months of 2026, the U.S. Food and Drug Administration (FDA) issued nine approvals in oncology, some of which are considered landmark and change the standard of care for cancer patients. 

Keep reading for a roundup of the new approvals and insights into how these integrate into the current therapeutic landscape.

Expanded Approval of Immunotherapy for Hodgkin Lymphoma 

Immune checkpoint inhibitors are a class of cancer immunotherapy that works by relieving certain inhibitory brakes on T cells and heightening their ability to recognize and attack cancer cells. Their use is being progressively expanded to more cancer types and earlier lines of treatment.

• In March 2026, the immune checkpoint inhibitor nivolumab (Opdivo) was approved in combination with the chemotherapy regimen doxorubicin, vinblastine, and dacarbazine for adult and pediatric patients 12 years and older with previously untreated, advanced (stage 3 or 4) classical Hodgkin lymphoma, which is the most common type of Hodgkin lymphoma. 
  
  In 2016, nivolumab was the first immune checkpoint inhibitor to be approved for Hodgkin lymphoma, which also marked the first immunotherapy to be approved for any hematologic malignancies. While the original approval of nivolumab was for patients whose disease had relapsed after multiple prior treatments, including autologous hematopoietic stem cell transplantation, its use in combination with chemotherapy has now been expanded as the new standard of care for patients with newly diagnosed stage 3-4 Hodgkin lymphoma. 
  
  At the same time, the FDA also converted previous accelerated approvals for Hodgkin lymphoma into traditional approvals, meaning that all nivolumab indications for relapsed or refractory Hodgkin lymphoma are now fully approved.

More Treatment Options for Patients With Multiple Myeloma 

As a result of two new approvals, a wider population of patients with multiple myeloma now has access to immunotherapy.

• The FDA granted approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed patients with multiple myeloma who are ineligible for autologous stem cell transplant. Daratumumab and hyaluronidase-fihj is an immunotherapy that combines a monoclonal antibody (daratumumab) targeting the protein CD38, which is highly expressed on the surface of multiple myeloma cells, and the hyaluronidase-fihj enzyme that partially breaks down the extracellular matrix so that daratumumab can reach CD38-expressing cells more effectively, resulting in cancer cell death. 
  
  While daratumumab and hyaluronidase-fihj was already available for the treatment of relapsed or refractory multiple myeloma or as a first-line therapy in combination with other treatments, the bortezomib, lenalidomide, and dexamethasone regimen remained the standard first-line therapy. With the recent approval, daratumumab and hyaluronidase-fihj became part of the new standard first-line therapy. 
  
• The FDA also approved teclistamab (Tecvayli) in combination with daratumumab and hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. Teclistamab is a bispecific T-cell engager that simultaneously binds the CD3 receptor present on T cells and the B-cell maturation antigen (BCMA) that is highly expressed on myeloma cells. As a result, T cells are activated to kill myeloma cells. 
  
  Teclistamab was granted accelerated approval as a monotherapy in 2022 for adult patients with relapsed or refractory multiple myeloma after multiple lines of therapy. The new approval also converted the accelerated approval to full approval.

First Immunotherapy and a First-in-class Drug Approval for Ovarian, Fallopian Tube, and Peritoneal Cancer 

• The first quarter of 2026 marked the approval of the first-in-class drug relacorilant (Lifyorli) in combination with nab-paclitaxel for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received at least one prior systemic therapy.
  
  Relacorilant is a selective glucocorticoid receptor antagonist, meaning that it binds the receptor and prevents its natural ligand cortisol from activating it. Cortisol is a stress hormone that regulates inflammation, metabolism, and immune responses. Studies have shown that cancer cells can co-opt this physiological response by overexpressing the glucocorticoid receptor to blunt the effects of chemotherapy and promote immune suppression.
  
  The approval of relacorilant marks a novel treatment mechanism in oncology related to the role of cortisol in cancer.

• Also in this quarter, pembrolizumab (Keytruda) was approved in combination with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in patients who have received one or two prior systemic therapies and whose tumors express the PD-L1 biomarker as determined by the PD-L1 IHC 22C3 pharmDx test, which was also simultaneously approved as a companion diagnostic device to identify eligible patients.
  
  This is the first approval for pembrolizumab or any immunotherapy specific to these tumor types. Earlier pembrolizumab use for these indications was specific for those with certain tumor-agnostic biomarkers, including microsatellite instability and tumor mutational burden. Therefore, while prior use was restricted to small patient subsets with specific molecular characteristics, with the new approval, immunotherapy becomes a standard therapeutic option for epithelial ovarian, fallopian tube, and primary peritoneal cancer. 

More Targeted Therapies Moving to the Frontline 

Three new FDA approvals extended the use of small molecule inhibitors to earlier lines of treatment.

• Zongertinib (Hernexeos) was granted accelerated approval for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors harbor activating mutations in the tyrosine kinase domain of the human epidermal growth factor receptor 2 (HER2). Zongertinib is a kinase inhibitor that targets both the wild-type and the mutated form of HER2. In 2025, it received accelerated approval as a first-in-class therapy for the same indication but only for patients who had received prior systemic treatment. The 2025 approval was based on clinical trial results that were presented at the AACR Annual Meeting 2025 and featured in a previous blog post. Under the new approval, zongertinib can be administered to newly diagnosed patients. 
  
• The small molecule BRAF inhibitor encorafenib (Braftovi) was granted traditional approval in combination with cetuximab (Erbitux) and the mFOLFOX6 chemotherapy regimen as a first-line treatment for adult patients with metastatic colorectal cancer with a BRAF V600E mutation. BRAF mutations cause abnormal activation of a cell signaling pathway that drives tumor growth. However, blocking the activity of mutated BRAF may not be enough to stop tumor growth, as another protein—epidermal growth factor receptor (EGFR)—becomes upregulated as a result, leading to therapy resistance. Cetuximab is a monoclonal antibody that targets EGFR. Clinical trial results showed that when given with a BRAF inhibitor, cetuximab improved response rates and survival compared with chemotherapy, and the combination is now standard first-line therapy for BRAF V600-mutated colorectal cancer. In 2024, this combination received accelerated approval, which has now been converted into full approval. 
  
• The FDA approved acalabrutinib (Calquence) in combination with venetoclax (Venclexta) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), two slow-growing types of non-Hodgkin lymphoma in which cancer cells accumulate in the blood and bone marrow and in the lymph nodes, respectively. Both treatments are taken orally.
  
  Acalabrutinib is a second-generation small molecule inhibitor of the Bruton tyrosine kinase (BTK), a component of the signaling pathways activated by the B-cell receptor, which is persistently activated in non-Hodgkin lymphoma cells. By preventing B-cell receptor signaling, acalabrutinib inhibits the growth, proliferation, and survival of malignant B cells. As discussed in a previous post, the molecule was previously approved in 2019 as a stand-alone BTK inhibitor therapy for both untreated and relapsed/refractory CLL or SLL. 
  
  Venetoclax is a small molecule inhibitor of the anti-apoptosis protein BCL-2. By blocking its activity, venetoclax causes death of malignant cells. It was approved as a first-line therapy for CLL and SLL in combination with a targeted immunotherapy in 2019.
  
  The new approval combined acalabrutinib with venetoclax for previously untreated patients. This combination represents the first all-oral, first-line regimen with a fixed treatment duration of 14 months for CLL and SLL. 

A First-of-its-kind Device to Treat Pancreatic Cancer

• The FDA approved Optune Pax, a portable, noninvasive device for the treatment of adult patients with locally advanced pancreatic cancer alongside chemotherapy. Its use involves applying electrically insulated adhesive patches directly to the patient’s skin on the abdomen. Through these patches, the device delivers alternating electrical fields, known as tumor treating fields (TTFields), that work by disrupting rapidly proliferating cancer cells while minimizing damage to healthy cells. Optune Pax represents the first FDA-approved therapy specific for locally advanced pancreatic cancer in nearly three decades. Similar devices have been previously approved for treatment of glioblastoma and lung cancer in combination with standard therapies. 
  
  Through the joint AACR-Novocure Tumor Treating Fields Research Grants, AACR supports innovative basic or translational research on TTFields to expand our understanding of the inner workings and the potential applications of this novel anticancer treatment modality.