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.

HER2DX Assay Predicts pCR Following Neoadjuvant THP in HER2+ Breast Cancer

July 10th 2025

HER2DX genomic scoring predicted pCR after neoadjuvant THP in a high-risk subgroup of patients with HER2-positive early breast cancer.

Studies Highlight Real-World Gaps in Third-Line mCRC and Evolving Role of Molecular Profiling in GI NETs

July 10th 2025

Rocío García-Carbonero, MD, discusses safety challenges in third-line mCRC and the role of molecular testing in aggressive GI neuroendocrine tumors.

Decitabine/Cedazuridine Plus Venetoclax sNDA Under FDA Review for Newly Diagnosed AML

July 9th 2025

Decitabine plus cedazuridine and venetoclax is under review for patients with newly diagnosed AML who are ineligible for intensive induction chemotherapy.

Long-Term Remission, OS With Cilta-Cel Set New Benchmarks for Survival Outcomes in R/R Myeloma

July 9th 2025

Peter Voorhees, MD, highlights 5-year follow-up data from the CARTITUDE-1 trial evaluating cilta-cel in relapsed/refractory multiple myeloma.

Fixed-Duration Ibrutinib Plus Venetoclax Demonstrates Long-Term Efficacy in Untreated CLL/SLL

July 9th 2025

Fixed-duration ibrutinib plus venetoclax was effective with nearly 70 months of follow-up in patients with untreated CLL/SLL.

Real-World ctDNA Positivity Predicts Poorer Outcomes in Early Breast Cancer

July 9th 2025

Real-world analysis showed ctDNA positivity was associated with higher recurrence risk and reduced overall survival in early breast cancer.

Novel Insights into Chromophobe Renal Cell Carcinoma Biology and Potential Therapeutic Strategies

July 9th 2025

Collaborative study investigates the unique immune features of rare cancer type, says Yale's David Braun, MD, PhD.

FDA Grants Fast Track Designation to TRE-515 Plus Radioligand Therapy in PSMA+ mCRPC

July 9th 2025

TRE-515 has received FDA fast track designation in combination with radioligand therapy for PSMA-positive mCRPC.

Pexidartinib Shows Long-Term Safety and Efficacy in Symptomatic TGCT

July 9th 2025

Pexidartinib generated long-term responses in patients with symptomatic tenosynovial giant cell tumors.

Bexobrutideg Earns EMA Orphan Drug Designation for Waldenström Macroglobulinemia

July 9th 2025

Bexobrutideg received European Medicines Agency orphan drug designation for Waldenström macroglobulinemia.

Post Hoc Data Highlight Utility of Fruquintinib Across Metastatic Subgroups in Refractory mCRC

July 9th 2025

Rocío García-Carbonero, MD, PhD, discusses findings from a subgroup analysis of FRESCO-2 with fruquintinib in refractory mCRC.

SUPRAME Trial Seeks to Establish IMA203 as the First TCR-Based Therapy for Cutaneous Melanoma

July 9th 2025

The phase 3 SUPRAME trial is comparing IMA203 vs investigator’s choice of therapy in patients with pretreated unresectable or metastatic cutaneous melanoma.

Bria-IMT Plus Checkpoint Inhibition Leads to 52% 1-Year OS Rate in Heavily Pretreated Metastatic Breast Cancer

July 8th 2025

Bria-IMT plus checkpoint inhibition displayed a potential overall survival benefit in heavily pretreated, hormone receptor–positive breast cancer.

Padeliporfin Vascular Targeted Photodynamic Therapy Safely Produces High Response Rates in Low-Grade Upper Tract Urothelial Cancer

July 8th 2025

Padeliporfin vascular targeted photodynamic therapy was highly active with a tolerable safety profile in low-grade upper tract urothelial cancer.

MB-101 Receives FDA Orphan Drug Designation for Astrocytoma and Glioblastoma

July 8th 2025

The FDA granted orphan drug designation to MB-101 for recurrent diffuse and anaplastic astrocytoma and glioblastoma.

FDA Grants Orphan Drug Designation to FF-10832 for Biliary Tract Cancer

July 8th 2025

FF-10832—an investigational liposomal formulation of gemcitabine—has received orphan drug designation from the FDA for biliary tract cancer.

Updated EHA-EMN Guidelines Include Melphalan Flufenamide for R/R Myeloma

July 8th 2025

The EHA-EMN guidelines now include melphalan flufenamide for certain patients with relapsed/refractory multiple myeloma.

Nogapendekin Alfa Inbakicept Plus BCG Approved in UK for BCG-Unresponsive NMIBC With CIS

July 8th 2025

The combination of nogapendekin alfa inbakicept and BCG is now approved in the United Kingdom for the treatment of patients with NMIBC with CIS.

EXPLORER Shrinks the Time it Takes for Imaging to Spot Cancer

July 8th 2025

Cancer parametric PET imaging with radioactive tracers is reduced from an hour to 20 minutes

Menin Inhibitors Are Poised to Expand Targeted Therapeutics to Broader AML Populations

July 8th 2025

Naval G. Daver, MD, and Eytan M. Stein, MD, discuss how menin inhibitors may transform the treatment paradigm in NPM1-mutant and NUP98 fusion AML.