Oncology Report – September 2025

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Oncology Updates — Aug 26 to Sep 2025

September delivered practice-relevant oncology updates worldwide — guideline shifts, pivotal trial readouts, new approvals, and high-impact AI tools. Below is a concise, clinician-first roundup. 🎗️

🩺Lung cancer

ESMO issues NSCLC guideline for early & locally advanced disease

New recommendations standardize biomarker-driven multimodality care in stage I–III NSCLC, including integration of IO/targeted therapy in pathways.

TT125-802 fast tracked for EGFR & KRAS G12C NSCLC

Dual-target small molecule receives FDA fast track in advanced NSCLC with EGFR or KRAS G12C mutations to speed development.

Zongertinib gets Breakthrough Therapy for HER2-mutant NSCLC

First-line designation in nonsquamous NSCLC with HER2 TKD mutations reflects strong activity in early data.

Olomorasib + pembrolizumab earns Breakthrough in KRAS G12C NSCLC

Combination strategy advances for metastatic KRAS G12C–mutant NSCLC to potentially extend durability of response.

Modeyso (dordaviprone) receives FDA accelerated approval for DMG

First systemic option for H3 K27M–mutant diffuse midline glioma in pediatric/young adult patients.

BA-101 (neu-cel) gains FDA orphan designation in glioblastoma

Cellular therapy advances in GBM, addressing a setting with persistent poor long-term survival.

Selumetinib approved for NF1 plexiform neurofibromas (≥1 year)

MEK inhibition extended to younger pediatric patients with inoperable PN, broadening access.

CER-1236 fast tracked in AML

Novel immunotherapy receives FDA fast track in relapsed/refractory AML to accelerate registrational path.

Ligufalimab earns orphan designation in AML

Anti-CD47 pathway therapy designated to support development in high-risk AML.

MNV-201 fast tracked for MDS

First-in-class approach in myelodysplastic syndromes gains FDA support to expedite trials.

Rina-S (ADC) gets Breakthrough in advanced endometrial cancer

Designation reflects notable responses in heavily pretreated disease; supports expedited development.

Relacorilant NDA accepted in platinum-resistant ovarian cancer

RLR-59 + nab-paclitaxel heads to FDA review after showing PFS benefit vs chemo alone.

Raludotatug deruxtecan (R-DXd) earns Breakthrough in gynecologic cancers

Broad designation covers recurrent ovarian and endometrial settings with high unmet need.

GLSI-100 fast tracked for HER2-positive breast cancer

DNA-based vaccine program advances in adjuvant HER2+ disease under fast track status.

Inlexzo (intravesical gemcitabine) approved for BCG-unresponsive NMIBC

New intravesical formulation adds an option for patients who fail BCG in non–muscle-invasive bladder cancer.

Ozuriftamab vedotin Phase 3 enabled in HPV+ oropharyngeal cancer

FDA Type-B meeting supports registrational development of a Nectin-4 ADC in head & neck cancer.

CRB-701 (Nectin-4 ADC) fast tracked for head & neck cancer

Fast track designation expedites evaluation in recurrent/metastatic HNSCC.

PANOVA-3: TTFields + chemo improves outcomes in pancreatic cancer

Phase 3 trial reports improved overall and pain-free survival versus chemotherapy alone in locally advanced disease.

Subcutaneous pembrolizumab approved across all solid tumors

5–7 minute injection (with hyaluronidase) enables faster delivery across all existing Keytruda indications.

City of Hope deploys HopeLLM across oncology workflows

Generative AI platform targets faster trial activation, note generation, and reduced administrative burden.

SOPHiA GENETICS joins Swiss precision-oncology AI initiative

Consortium integrates clinical genomics and AI analytics to enhance decision support across cancer centers.

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