FDA Approves Wave of Oncology Drugs and Biosimilars in November 2025, Expanding Treatment Access
Key Insights
The FDA approved multiple oncology treatments in November 2025, including Komzifti (search) for NPM1 (search)-mutant AML, Imdelltra for extensive-stage small cell lung cancer, and Hyrnuo (search) for HER2 (search)-mutant NSCLC.
Several biosimilar approvals expanded access to cancer treatments, with Poherdy (search) becoming the first interchangeable biosimilar to Perjeta for HER2 (search)-positive breast cancer.
Combination therapies received approval for various cancers, including Keytruda with Padcev for muscle invasive bladder cancer and Imfinzi plus FLOT for gastric adenocarcinoma.
The U.S. Food and Drug Administration issued multiple oncology approvals in November 2025, significantly expanding treatment options for patients with various cancers including acute myeloid leukemia, lung cancer, breast cancer, and bladder cancer. The approvals encompassed both novel therapies and biosimilar alternatives that promise to increase access while potentially reducing treatment costs.
Novel Targeted Therapies Address Unmet Medical Needs
Komzifti Approved for NPM1-Mutant AML
The FDA approved Komzifti (search) (ziftomenib), a menin (search) inhibitor, for adults with relapsed or refractory acute myeloid leukemia driven by an NPM1 (search) mutation and lacking alternative treatment options. The KO-MEN-001 study evaluated 112 patients and demonstrated a complete remission plus CR with partial hematologic recovery rate of 21.4% with a median response duration of approximately five months. Additionally, some patients experienced improvements in transfusion dependence.
Imdelltra Gains Traditional Approval for Small Cell Lung Cancer
Imdelltra (tarlatamab-dlle) earned traditional approval for adults with extensive-stage small cell lung cancer whose disease progressed after platinum-based chemotherapy. In the DeLLphi-304 trial, patients who received Imdelltra achieved a median overall survival of 13.6 months compared with 8.3 months for those who received standard chemotherapy. Median progression-free survival was also longer with Imdelltra. Improvements in shortness of breath were noted at week 18, offering an additional clinical benefit for patients.
Hyrnuo Targets HER2-Mutant NSCLC
Hyrnuo (search) (sevabertinib) received approval for adults with locally advanced or metastatic non-squamous non-small cell lung cancer with HER2 (search) tyrosine kinase domain activating mutations. Patients must have previously received systemic therapy and have their mutation identified through an FDA-approved test. The SOHO-01 trial measured confirmed objective response rate and duration of response, supporting the approval. The agency also approved the Oncomine Dx Target Test as a companion diagnostic to help identify eligible patients.
Biosimilar Approvals Expand Access to Cancer Care
First Interchangeable Perjeta Biosimilar
Poherdy (search) (pertuzumab-dpzb) received FDA approval as the first interchangeable biosimilar to Perjeta for HER2 (search)-positive breast cancer. The treatment is indicated for metastatic disease in combination with Herceptin (trastuzumab) and docetaxel, neoadjuvant therapy for tumors greater than 2 centimeters or node-positive disease and adjuvant therapy for early-stage disease at high risk of recurrence. As an interchangeable biosimilar, Poherdy is expected to increase access to HER2-targeted therapy and potentially reduce treatment costs.
Denosumab Biosimilars Receive Interchangeable Status
The FDA approved two biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo), as interchangeable options for all approved indications of Prolia and XGEVA. These medications address conditions involving bone loss, including osteoporosis in postmenopausal women and men at high fracture risk, bone loss caused by glucocorticoid treatment and bone loss in women receiving aromatase inhibitors for breast cancer. Both approvals allow pharmacy substitution for the original medicines depending on state regulations, which may increase access and reduce financial burden.
Combination Therapies Show Promise Across Multiple Cancers
Bladder Cancer Treatment Advances
The FDA approved Keytruda (pembrolizumab) or Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) with Padcev (enfortumab vedotin-ejfv) as neoadjuvant therapy followed by adjuvant therapy after cystectomy for cisplatin-ineligible adults with muscle invasive bladder cancer. In the KEYNOTE-905/EV-303 study, median event-free survival and overall survival were not reached in the combination arm, compared with 15.7 months and 41.7 months, respectively, in the surgery-alone group.
Gastric Cancer Treatment Option
Imfinzi (durvalumab) plus FLOT (fluorouracil, leucovorin, oxaliplatin and docetaxel) received approval as presurgical and postsurgical treatment for adults with resectable gastric or gastroesophageal junction adenocarcinoma. The MATTERHORN trial enrolled 948 patients and demonstrated that median event-free survival was not reached for the Imfinzi arm and was 32.8 months for the placebo arm. The pathologic complete response rate was 19.2% with Imfinzi and FLOT compared with 7.2% with placebo and FLOT.
Hematologic Malignancies See New Treatment Options
Multiple Myeloma Prevention Strategy
Darzalex Faspro (daratumumab and hyaluronidase-fihj) received approval for adults with high-risk smoldering multiple myeloma, a precancerous condition that carries a higher likelihood of progressing to active multiple myeloma. The approval was supported by data from the AQUILA study, which compared the treatment with active monitoring in 390 patients. Median progression-free survival was not reached for patients who received Darzalex Faspro and was 41.5 months for those in the monitoring group.
Follicular Lymphoma Treatment Advances
The FDA approved Epkinly (epcoritamab-bysp) with Revlimid (lenalidomide) and Rituxan (rituximab) for relapsed or refractory follicular lymphoma. The agency also granted traditional approval for Epkinly monotherapy after at least two prior systemic therapies. In the EPCORE FL-1 trial of 488 patients, the combination improved progression-free survival and achieved an 89% overall response rate compared with 74% in the control arm.