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.

SAR446523 Receives FDA Orphan Drug Designation for R/R Myeloma

August 9th 2025

The FDA granted orphan drug designation to SAR446523 for relapsed/refractory multiple myeloma.

The OncFive: Top Oncology Articles for the Week of 8/3

August 9th 2025

The FDA grants accelerated approval to zongertinib in lung cancer, clears dordaviprone in glioma, and awards priority review to liso-cel sBLA in MZL.

HER2-Targeted Therapies and Chemoimmunotherapy Continue to Advance Biliary Tract Cancer Management

August 8th 2025

Tanios S. Bekaii-Saab, MD, highlights how HER2-directed agents, chemoimmunotherapy, and biomarker-driven strategies are expanding options for biliary tract cancers.

Acalabrutinib Plus BR Highlights Evolving First-Line SOC for High-Risk Mantle Cell Lymphoma

August 8th 2025

Martin Dreyling, MD, PhD, discusses clinical trial findings with acalabrutinib plus BR in patients with high-risk mantle cell lymphoma.

FDA Grants Accelerated Approval to Zongertinib for Nonsquamous NSCLC With HER2 TKD Mutations

August 8th 2025

The FDA granted accelerated approval to zongertinib for pretreated, unresectable or metastatic non–small cell lung cancer harboring HER2 mutations.

Novel Fox Chase Cancer Center Study Uses New Methods to Show How Fast Breast Cancers Grow and How Surgery Delays Affect Cancer Staging

August 8th 2025

Richard Bleicher, MD, FACS, discusses using a novel method to analyze tumor growth rates.

NMPA Accepts sNDA for Frontline Toripalimab Plus Disitamab Vedotin in HER2+ Urothelial Carcinoma

August 8th 2025

China’s NMPA has accepted the sNDA for first-line toripalimab plus disitamab vedotin in HER2-expressing locally advanced or metastatic urothelial carcinoma.

FDA Grants RMAT Designation to Novel CAR T-Cell Therapy for R/R Mantle Cell Lymphoma

August 8th 2025

The FDA granted regenerative medicine advanced therapy designation to GLPG5101 for relapsed/refractory mantle cell lymphoma.

Chromophobe RCC Microenvironment Study Shows Determinants of Impaired Antitumor Immunity

August 8th 2025

Although chromophobe RCC has an immune-cold environment, ferroptosis induction may be a promising target for managing tumor resistance in this subtype.

NSCLC Experts Highlight Clinical Trials to Watch in 2025

August 8th 2025

Lung cancer experts share upcoming, potentially practice-informing clinical trials that are expected to read out in the second half of 2025.

Real-World Data Support Bevacizumab-Based Quadruplet Therapy in Frontline Advanced Cervical Cancer

August 8th 2025

Alberto Farolfi, MD, PhD, shares results from a real-world study of first-line bevacizumab, pembrolizumab, and platinum chemotherapy in cervical cancer.

From BTK Inhibitors to CAR T-Cell Therapies: Hematologic Malignancies Landscape Sees an ‘Explosion of New Therapies’

August 7th 2025

Kathleen A. Dorritie, MD, highlights important NCCN guideline updates and research to watch in hematologic malignancies.

FDA Approval of Mirdametinib Reduces Treatment Barriers for Adult Patients With NF1-Associated PNs

August 7th 2025

Timothy Gershon, MD, PhD, discusses how the FDA approval of mirdametinib will affect the treatment paradigm for adult patients with NF1-associated PNs.

Epcoritamab Plus Rituximab and Lenalidomide Hits Both Primary End Points in R/R Follicular Lymphoma

August 7th 2025

Epcoritamab plus rituximab and lenalidomide met the dual primary end points of the EPCORE FL-1 in relapsed/refractory follicular lymphoma.

ASCO Updates Living Guidelines to Include New Treatment Strategies for NSCLC With/Without Driver Alterations

August 7th 2025

ASCO updated their clinical practice guidelines for stage IV NSCLC with or without a driver alteration.

MD Anderson Ranked No. 1 in the Nation for Cancer Care

August 7th 2025

The MD Anderson Cancer Center was ranked number one in the nation for cancer care in U.S. News & World Report’s 2024-25 "Best Hospitals" survey.

NCCN Adds LEMS Antibody Testing, Treatment Recommendations to Clinical Practice Guidelines in SCLC

August 7th 2025

The NCCN Clinical Practice Guidelines in Oncology for SCLC added new recommendations for LEMS, the use of amifampridine, and VGCC antibody testing.

Botensilimab Plus Balstilimab Shows Durable Activity in Refractory CRC Across Lines of Therapy

August 7th 2025

Botensilimab plus balstilimab displayed durable responses in refractory CRC, including in heavily pretreated patient subsets.

FDA Grants Fast Track Designation to Birelentinib for R/R CLL/SLL

August 7th 2025

Birelentinib received fast track designation from the FDA for relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Novel ADC Sigvotatug Vedotin Generates Early Efficacy in NSCLC

August 7th 2025

Rachel E. Sanborn, MD, discusses the novel IB6-directed ADC sigvotatug vedotin for the treatment of patients with NSCLC.