All Oncology News

The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.

MVdeltaC Receives FDA Orphan Drug Designation in Pleural Mesothelioma

June 12th 2025

The oncolytic virus candidate MVdeltaC has received FDA orphan drug designation for the treatment of patients with pleural mesothelioma.

FDA Grants Fast Track Designation to CHM CDH17 for Gastroenteropancreatic NETs

June 12th 2025

CHM CDH17 has received fast track designation from the FDA for the treatment of patients with gastroenteropancreatic neuroendocrine tumors.

New EBMT Machine Learning Model Outperforms Available Tools in Predicting Transplant Risk in Myelofibrosis

June 12th 2025

The EBMT have developed a machine learning model designed to identify and stratify transplant risk for patients with myelofibrosis.

Obrixtamig Plus Topotecan Could Address a Second-Line Need in SCLC

June 12th 2025

Obrixtamig combined with topotecan demonstrated favorable safety and early efficacy in relapsed/refractory SCLC.

FDA Grants Fast Track Designation to RAD101 for Imaging of Brain Metastases

June 12th 2025

The FDA granted fast track designation to RAD101 for imaging of cerebral metastases from various solid tumors, including leptomeningeal metastases.

FDA Approves Tablet Formulation of Zanubrutinib for B-Cell Malignancies

June 11th 2025

The FDA has approved a tablet formulation of zanubrutinib for use in all 5 approved indications of the capsule formulation.

Olaparib/Temozolomide Fails to Meet PFS End Point in Previously Treated Advanced Uterine Leiomyosarcoma

June 11th 2025

Olaparib plus temozolomide was not superior to pazopanib or trabectedin for the treatment of patients with advanced uterine leiomyosarcoma.

Darolutamide/ADT Combo Delays Pain Progression and Enhances QOL in mHSPC

June 11th 2025

Alicia Morgans, MD, MPH, discusses findings from a QOL analysis of the ARANOTE trial, which evaluated darolutamide plus ADT in patients with mHSPC.

Mayo Clinic Takes the Next Step in Making Heavy Particle Therapy Available in the Western Hemisphere for Patients with Aggressive Cancers

June 11th 2025

The Mayo Clinic's new facility will house the first carbon ion therapy program in the Western Hemisphere.

FDA Approves Taletrectinib for ROS1+ Advanced NSCLC

June 11th 2025

The FDA has approved taletrectinib for use in patients with ROS1-positive advanced non–small cell lung cancer.

Sacituzumab Tirumotecan Plus Tagitanlimab Receives Breakthrough Therapy Designation in China for First-Line, Nonsquamous NSCLC

June 11th 2025

China’s Center for Drug Evaluation granted breakthrough therapy designation to sacituzumab tirumotecan for nonsquamous non–small cell lung cancer.

Iopofosine I-131 Demonstrates Safety and Early Efficacy in Pediatric R/R High-Grade Glioma

June 11th 2025

Data from the phase 1 CLOVER-2 trial demonstrated the safety and activity of iopofosine I-131 in relapsed/refractory pediatric high-grade glioma.

Phase 1 Data Pave the Way for Further Investigation of IMA203 in Advanced Melanoma

June 11th 2025

Jason J. Luke, MD, FACP, discusses data for the PRAME-targeted TCR T-cell therapy IMA203 in advanced or metastatic melanoma.

The Role of Liquid Biopsies in Precision Approaches for Breast Cancer Therapy

June 11th 2025

Liquid biopsy approaches aid in precision therapy selection for patients with breast cancer in a noninvasive manner.

DESTINY-Breast09 and Ongoing Trials Underscore Shifting ADC Landscape in HER2+ Breast Cancer

June 11th 2025

Hope S. Rugo, MD, discusses key considerations and unanswered questions arising from the DESTINY-Breast09 trial in HER2-positive breast cancer.

EV-302 Regimen Shows Sustained Efficacy Vs Chemo Across Key Subgroups of Urothelial Cancer

June 10th 2025

First-line enfortumab vedotin plus pembrolizumab continued to demonstrate efficacy across subgroups of locally advanced or metastatic urothelial carcinoma.

RLY-2608 Plus Fulvestrant Demonstrates Efficacy in PIK3CA-Mutated, HR+/HER2– Advanced Breast Cancer

June 10th 2025

Sarah Sammons, MD, discusses data from the phase 1 ReDiscover trial of RLY-2608 plus fulvestrant in HR-positive, HER2-negative breast cancer.

T-DXd Plus Pertuzumab Displays Significant PFS Benefit Over SOC Therapy in Frontline HER2+ Advanced Breast Cancer

June 10th 2025

Sara M. Tolaney, MD, MPH, discusses data showing that T-DXd plus pertuzumab improved PFS vs SOC THP in first-line HER2-positive breast cancer.

Biomarkers Hold Clue in Treating Aggressive Prostate Cancer

June 10th 2025

Clinical trial tests new treatment approach, offers hope for personalized therapies.

China’s Center for Drug Evaluation Accepts MAA for Pimicotinib in TGCT

June 10th 2025

The Center for Drug Evaluation of the Chinese NMPA has accepted the marketing authorization application for pimicotinib in patients with TGCT.