November 2025: Key FDA Highlights in Oncology

November 2025 was a landmark month for oncology, characterized by a wave of pivotal regulatory decisions from the FDA that promise to reshape the treatment landscape across numerous cancer types. The month saw a balanced mix of traditional and accelerated approvals, along with the introduction of new biosimilar and companion diagnostic technologies.

Key regulatory milestones included the following:

• A major advance in perioperative treatment with the approval of durvalumab for resectable gastric and gastroesophageal junction adenocarcinoma
• A significant step in bladder cancer with the approval of the pembrolizumab and enfortumab vedotin combination for muscle-invasive disease
• New options for lung cancer patients, including traditional approval for tarlatamab in extensive-stage small cell lung cancer and accelerated approval for sevabertinib in HER2-mutated non–small cell lung cancer (NSCLC).

In hematologic malignancies, new hope emerged with the approval of ziftomenib for NPM1-mutant acute myeloid leukemia (AML) and the first-ever treatment for high-risk smoldering multiple myeloma (SMM), subcutaneous daratumumab.

From a flurry of important approvals to a number of fast track and orphan drug designations for agents in the pipeline, this roundup provides a comprehensive overview of all the critical FDA actions that defined oncology progress in November 2025.

Approvals

FDA Approves Subcutaneous Daratumumab for Smoldering Multiple Myeloma

The FDA has approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for the treatment of adult patients with high-risk SMM, making the CD38-directed antibody the first treatment approved in this setting.

FDA Approves Generic Dasatinib, Expanding Access to Key TKI

The FDA has granted final approval for an abbreviated new drug application for generic dasatinib (Sprycel) tablets in multiple dosage strengths, a regulatory milestone expected to improve market access and cost efficiency for a critical therapeutic agent in the treatment of Philadelphia chromosome–positive chronic myeloid leukemia and acute lymphoblastic leukemia (ALL).

FDA Clears New CDx for Pembrolizumab/Lenvatinib in Endometrial Carcinoma

The FDA has approved the OncoMate MSI Dx Analysis System as a companion diagnostic for pembrolizumab plus lenvatinib (Lenvima) in microsatellite-stable, defined as not microsatellite instability-high, endometrial carcinoma, a key step toward precision treatment strategies.

FDA Approves Ziftomenib in NPM1-Mutant Acute Myeloid Leukemia

The FDA has approved the new drug application (NDA) for ziftomenib (Komzifti) in the treatment of relapsed or refractory NPM1-mutant AML.

FDA Approves Novel Interchangeable Biosimilar for Pertuzumab in HER2+ Breast Cancer

The FDA has granted approval for pertuzumab-dpzb (Poherdy), designating it as the first interchangeable biosimilar to the reference product pertuzumab (Perjeta). This significant regulatory action provides clinicians with a crucial new treatment option for patients diagnosed with HER2-positive breast cancer across multiple disease settings, enhancing therapeutic accessibility and potentially mitigating drug cost burdens within oncology care.

FDA Authorizes EXENT System to Aid Myeloma Diagnosis

The FDA has granted 510(k) clearance to the EXENT System, a fully automated device for assessing monoclonal gammopathies, to aid in the diagnosis of multiple myeloma. The system offers easy implementation and operation and enhances workflow efficiency, providing valuable utility for clinical laboratories.

FDA Approves Epcoritamab-Based Regimen in Follicular Lymphoma

The FDA has approved epcoritamab (Epkinly) plus rituximab (Rituxan) and lenalidomide (Revlimid) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma. This marks the first bispecific antibody combination available as a second-line treatment option in this patient population.

FDA Approves Selumetinib for Adult NF1 With Plexiform Neurofibromas

The FDA has approved selumetinib (Koselugo) for the treatment of adult patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas.

FDA Grants Daratumumab Traditional Approval for Newly Diagnosed Light Chain Amyloidosis

The FDA has granted a traditional approval to daratumumab with bortezomib (Velcade), cyclophosphamide, and dexamethasone for patients with newly diagnosed light chain amyloidosis.

FDA Approves Sevabertinib in HER2-Mutated Nonsquamous NSCLC

The FDA has granted an accelerated approval to sevabertinib (Hyrnuo) for the treatment of adult patients with previously treated locally advanced or metastatic, nonsquamous NSCLC whose tumors harbor HER2 tyrosine kinase domain mutations as detected by an FDA-approved test.

FDA Grants Full Approval to Tarlatamab in Small Cell Lung Cancer

The FDA has granted full approval to tarlatamab-dlle (Imdelltra) for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. The approval is based on findings from the phase 3 DeLLphi-304 trial (NCT05740566) in which the bispecific T-cell engager tarlatamab reduced the risk of death by 40% vs investigator's choice of standard chemotherapy.

FDA Approves 2 New Denosumab Biosimilars

The FDA has approved new denosumab biosimilars, denosumab-desu (Osvyrti and Jubereq), for the treatment of osteoporosis and management of skeletal-related events in cancer. These approvals provide new therapeutic options clinically equivalent to the reference products, Prolia and Xgeva.

FDA Approves Enfortumab Vedotin Plus Pembrolizumab for MIBC

The FDA has approved enfortumab vedotin (Padcev) plus pembrolizumab (Keytruda) for the treatment of patients with muscle-invasive bladder cancer. The FDA decision was based on the results of the phase 3 EV-303 clinical trial (NCT03924895). Enfortumab plus pembrolizumab reduced the risk of recurrence, progression, or death by 60% and the risk of death by 50% compared with surgery alone.

FDA Approves Durvalumab Plus FLOT in Early Stage Gastric/GEJ Cancers

The FDA has approved durvalumab (Imfinzi) plus fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) for the treatment of patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers.

Fast Track Designations

FDA Fast-Tracks Bispecific ADC AVZO-1418 for EGFR-Mutated Pretreated NSCLC

The FDA has granted fast track designation to the EGFR/HER3 bispecific antibody-drug conjugate (ADC) AVZO-1418 for treatment of patients with EGFR-mutated, tyrosine kinase inhibitor (TKI)–pretreated NSCLC.

FDA Grants Fast Track to Alnodesertib Combo for Metastatic Colorectal Cancer

The FDA has granted fast track designation to the combination of alnodesertib (formerly ART0380) and irinotecan for the treatment of ATM-negative metastatic colorectal cancer.

FOG-001 Receives FDA Fast Track Designation in Desmoid Tumors

The FDA has granted fast track designation to FOG-001 for the treatment of desmoid tumors. This designation follows preliminary data first released at the European Society of Medical Oncology Congress 2025 in October.

FDA Fast Tracks Anti-CD127 Monoclonal Antibody for Acute Lymphoblastic Leukemia

4A10, a monoclonal antibody targeting interleukin-7 receptor alpha (IL-7Rα; CD127), has received fast track designation from the FDA for the treatment of patients with relapsed or refractory ALL.

FDA Fast Tracks PET Diagnostic Agent for Clear Cell Renal Cell Carcinoma

The FDA has awarded fast track desgination to [68Ga]Ga-DPI-4452 (ITM-94), a promising noninvasive diagnostic agent for clear cell renal cell carcinoma.

FDA Grants Fast Track to Novel C-Mod DPTX3186 in Gastric Cancer

DPTX3186, a first-in-class, orally available condensate modulating agent (c-mod), has earned FDA fast track designation for the treatment of gastric cancer.

Orphan Drug Designations

FDA Grants Orphan Drug Status to Novel CD33-Directed Immunotherapy for AML

The FDA has granted orphan drug designation to the AML treatment candidate M2T-CD33 (LTI-214), signaling a potential entrance for a novel, differentiated therapeutic approach to this aggressive disease.

FDA Grants Tinostamustine Orphan Drug Designation for Malignant Gliomas

The investigational, potentially first-in-class agent tinostamustine (EDO-S101) has earned FDA orphan drug designation for first-line treatment of malignant gliomas, including the aggressive, difficult-to-treat glioblastoma multiforme.

Novel TROP2-Targeting ADC Gains FDA Orphan Drug Status in Cholangiocarcinoma

OBI-902, a novel TROP2-targeting ADC, has been awarded FDA orphan drug designation in cholangiocarcinoma.

NDA Submissions

FDA Accepts NDA for 177Lu-edotreotide in GEP-NETs

The FDA has accepted the NDA of the synthetic, targeted radiotherapeutic agent 177Lu-edotreotide (ITM-11) for treatment of patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) . A Prescription Drug User Fee Act (PDUFA) target date of August 28, 2026, has been set.

FDA Accepts NDA for Zidesamtinib in Advanced ROS1+ NSCLC

The FDA has accepted the NDA for zidesamtinib (NVL-520), an investigational ROS1-selective inhibitor. The FDA has set a PDUFA target action date of September 18, 2026.

Rolling NDA Submission Begins for Zipalertinib in EGFR Exon 20+ NSCLC

The rolling submission of a NDA to the FDA has been initiated for zipalertinib (CLN-081) for treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy.

FDA Grants Priority Review to Next-Gen BCL2 Inhibitor Sonrotoclax in MCL

Sonrotoclax, an investigational, next-generation BCL2 inhibitor, has received priority review designation from the FDA for the treatment of adult patients with R/R mantle cell lymphoma following prior therapy with a Bruton tyrosine kinase inhibitor.