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.

FDA Grants Orphan Drug Designation to ICT01 for Acute Myeloid Leukemia

July 18th 2025

ICT01 has received orphan drug designation from the FDA for the treatment of patients with acute myeloid leukemia.

Belzutifan Prolongs Quality-Adjusted Time Without Symptoms or Toxicity in Advanced RCC

July 18th 2025

Treatment with belzutifan increased the time without progression or toxicity vs everolimus in patients with advanced RCC.

Metastasis-Directed Radiotherapy Yields Durable Disease Control Without Systemic Therapy in Oligometastatic RCC

July 18th 2025

Metastasis-directed radiotherapy without systemic therapy demonstrated an improved safety profile vs immunotherapy and tyrosine kinase inhibitors.

ADC-, Bispecific Antibody–Based Therapies Help Build a New Treatment Paradigm in EGFR+ NSCLC

July 18th 2025

Sandip P. Patel, MD, discusses targeted therapy combination regimens in EGFR-mutated NSCLC.

Nimotuzumab Plus Chemotherapy Yields Survival Benefits in Frontline Recurrent/Persistent Cervical Cancer

July 18th 2025

Nimotuzumab plus chemotherapy was more effective than chemotherapy alone in patients with recurrent or persistent cervical cancer.

Investigational Neoantigen Vaccines Target RCC Mutations and Drive Durable T-Cell Activity

July 17th 2025

David A. Braun, MD, PhD, discusses findings from a study of personalized neoantigen vaccines in patients with high-risk, resectable ccRCC.

Novel CAR T-Cell Therapy Could Pave the Way for Improvements in Advanced ccRCC Management

July 17th 2025

Research supports the use of novel CAR T-cell therapy targeting CAIX and CD70 for the treatment of patients with advanced ccRCC.

Research Leaders Across New York State Form Empire State Cellular Therapy Consortium

July 17th 2025

Research centers across New York State are collaborating to develop cell therapies for cancer to expand progress in the emerging field of cell therapy.

FDA’s ODAC Votes Against Risk:Benefit Profiles of Belantamab Mafodotin Combos in R/R Myeloma

July 17th 2025

The FDA’s ODAC voted against the risk/benefit profiles of belantamab mafodotin–based combinations in relapsed/refractory multiple myeloma.

FDA Grants Priority Review to TAR-200 for BCG-Unresponsive High-Risk NMIBC

July 17th 2025

The FDA has granted priority review to TAR-200 for BCG-unresponsive, high-risk NMIBC with CIS, with or without papillary tumors.

FDA Grants Breakthrough Therapy Designation to Frontline T-DXd Plus Pertuzumab in HER2+ Metastatic Breast Cancer

July 17th 2025

The FDA granted breakthrough therapy designation to first-line trastuzumab deruxtecan plus pertuzumab in HER2-positive metastatic breast cancer.

Second-Generation BTK Inhibitors Set the Stage for Future Advances in CLL Management

July 17th 2025

Cyrus M. Khan, MD, discusses the role of second-generation BTK inhibitors and their implications for clinical practice in the CLL treatment paradigm.

Mirdametinib Represents Long-Awaited Approved Treatment Option for Adult NF1-Associated PNs

July 17th 2025

Justin T. Jordan, MD, MPH, FAAN, discusses the implications of the FDA approval of mirdametinib for adult NF1-associated plexiform neurofibromas.

DESTINY-Breast09 Data Spark Debate on Sequencing and Frontline Maintenance Strategies in HER2+ Breast Cancer

July 17th 2025

Laura Huppert, MD, discusses the implications of data with first-line T-DXd plus pertuzumab in HER2-positive metastatic breast cancer.

Domvanalimab Plus Zimberelimab and Chemo Set for Phase 3 Study After Showing Efficacy in Untreated Upper GI Cancers

July 16th 2025

STAR-221 will evaluate domvanalimab plus zimberelimab and chemotherapy for the first-line treatment of patients with gastric, GEJ, or esophageal adenocarcinoma.

FDA Grants Fast Track Status to ZEN-3694 Plus Abemaciclib for Unresectable or Metastatic NUT Carcinoma

July 16th 2025

ZEN-3694 has received fast track designation from the FDA for use in combination with abemaciclib for patients with previously treated NUT carcinoma.

Long-Term Follow-Up Data With IO/IO and IO/TKI Combinations Better Inform Clinical Decision-Making in Advanced ccRCC

July 16th 2025

Hans Hammers, MD, PhD, discusses the efficacy, safety, and clinical utilization of IO/IO and IO/TKI combinations in advanced clear-cell RCC.

AI Outperforms People in Scoring Melanoma Tumor-Infiltrating Immune Cells

July 16th 2025

A Yale study found that open-source AI tools outperformed traditional, visual methods for measuring the abundance of melanoma biomarkers.

CUE-101 Plus Pembrolizumab Yields 50% ORR in HPV+ HNSCC With Low PD-L1 Expression

July 16th 2025

In patients with HPV16-positive HNSCC, CUE-101 plus pembrolizumab generated 2 complete responses and a 12-month overall survival rate of 88%.

FDA Grants Orphan Drug Designation to SH-110 for Oral Suspension in Glioma

July 16th 2025

SH-110 received orphan drug designation from the FDA for the treatment of patients with glioma.