October 2025: A Look at FDA Oncology Approvals and Designations
October 2025 marks a pivotal month in oncology, with the FDA granting multiple approvals and designations that enhance treatment options for various cancers. This article delves into the most notable FDA news and designations that will shape cancer care moving forward.
Key Approvals and Designations
Trastuzumab deruxtecan (T-DXd) Plus Paclitaxel, Trastuzumab, and Pertuzumab (THP) for HER2+ Breast Cancer: On October 1, the FDA accepted a supplemental biologics license application (sBLA) for this combination therapy, which is set to be reviewed by May 18, 2026. This therapy is designed for neoadjuvant treatment in adult patients with HER2-positive stage 2 or 3 breast cancer.
ETX-636 for PIK3CA-Mutant, HR+ Breast Cancer: The FDA granted fast track designation to ETX-636, a pan mutant-specific allosteric PIK3CA inhibitor, for treating patients with PIK3CA-mutant, HR-positive, HER2-negative advanced breast cancer.
Lurbinectedin and Atezolizumab for ES-SCLC Maintenance: On October 2, the FDA approved the combination of lurbinectedin (Zepzelca) and atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybrezas) as a first-line maintenance treatment in patients with ES-SCLC whose disease has not progressed after first-line induction therapy.
AMXT 1501 and DFMO Combination for Neuroblastoma: The FDA granted orphan drug designation to AMXT 1501 in combination with difluoromethylornithine (DFMO) for treating patients with neuroblastoma.
Orca-T for Hematologic Malignancies: On October 6, the FDA accepted for priority review the biologics license application of Orca-T, an investigational allogeneic T-cell immunotherapy, for treating hematologic malignancies including acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndromes.
Cemiplimab for Adjuvant Cutaneous Squamous Cell Carcinoma: The FDA approved cemiplimab (Libtayo) as an adjuvant treatment in adults with high-risk CSCC on October 8.
WTX-124 for Refractory Melanoma: The FDA granted fast track designation to WTX-124 for treating patients with locally advanced or metastatic cutaneous melanoma that has progressed after standard-of-care immunotherapy.
ADCE-D01 for Soft Tissue Sarcoma Treatment: On October 9, the FDA granted fast track designation to ADCE-D01, an antibody-drug conjugate (ADC), for treating soft tissue sarcoma.
Ficerafusp Alfa for HPV-Negative R/M HNSCC: The FDA granted breakthrough therapy designation to ficerafusp alfa (BCA101) in combination with pembrolizumab (Keytruda) for the first-line treatment of HPV-negative, recurrent or metastatic head and neck squamous cell carcinoma on October 13.
Sonrotoclax for R/R MCL: On October 14, the FDA granted breakthrough therapy designation to sonrotoclax (BGB-11417), an investigational BCL-2 inhibitor, for treating adult patients with relapsed or refractory mantle cell lymphoma following therapy with a BTK inhibitor and an anti-CD20 agent.
NG-350A for pMMR Rectal Cancer: NG-350A, an intravenously delivered oncolytic immunotherapy, was granted fast track designation by the FDA for treating mismatch repair-proficient (pMMR) locally advanced rectal cancer on October 14.
MNV-201 for Low-Risk MDS: The FDA granted orphan drug designation to MNV-201, an investigational mitochondrial cell therapy, for treating myelodysplastic syndrome on October 15.
EO2463 for Follicular Lymphoma: On October 16, the FDA granted fast track designation to EO2463, a novel immunotherapy, for treating follicular lymphoma, based on positive interim data from the SIDNEY trial.
XS003 for Chronic Myeloid Leukemia: The FDA accepted a new drug application for XS003, a formulation referencing nilotinib (Tasigna), for treating chronic myeloid leukemia on October 21.
Enfortumab Vedotin/Pembro in MIBC: The FDA granted priority review to the sBLA of enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab, radical cystectomy, and standard pelvic lymph node dissection for muscle-invasive bladder cancer on October 21.
MT-125 for Glioblastoma: The FDA gave fast track designation to MT-125, a first-in-class dual small-molecule inhibitor, for treating glioblastoma on October 22.
Pamlectabart Tismanitin for Myeloma Treatment: On October 23, the FDA granted fast track designation to pamlectabart tismanitin (HDP-101), a novel amanitin-based ADC, for treating relapsed or refractory multiple myeloma.
Revumenib in Mutant NPM1 AML: The FDA approved revumenib (Revuforj) for treating relapsed or refractory NPM1-mutant AML on October 24, supported by positive data from the AUGMENT-101 trial.
Zenocutuzumab for Advanced Cholangiocarcinoma: The FDA granted breakthrough therapy designation to zenocutuzumab (Bizengri) for treating advanced unresectable or metastatic cholangiocarcinoma harboring an NRG1 gene fusion on October 24.
JSKN003 for Platinum-Resistant Ovarian Cancer: On October 27, the FDA granted fast track designation to JSKN003, a biparatopic HER2-targeting ADC, for treating platinum-resistant ovarian cancer, regardless of HER2 expression.
Daraxonrasib for Pancreatic Cancer: Daraxonrasib (RMC-6236), an oral, multiselective inhibitor, was awarded orphan drug designation by the FDA for treating pancreatic cancer on October 27.
ZEN-3694 for NUT Carcinoma: The FDA granted orphan drug designation to ZEN-3694, a novel oral therapy, for treating NUT carcinoma on October 27.
Conclusion
These approvals and designations demonstrate the FDA's commitment to accelerating the development and availability of innovative oncology therapeutics. As the field of oncology continues to evolve, these advancements will play a crucial role in improving treatment outcomes and quality of life for patients with various cancers.
