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.

Updates to MDS Classification Complicate Yet Better Inform Treatment Navigation in MDS

February 15th 2024

Mikkael A. Sekeres, MD, MS, discusses the influence of therapeutic developments and conflicting classification systems on the management of MDS.

BLA Resubmitted to FDA for Denileukin Diftitox in Relapsed/Refractory Cutaneous T-cell Lymphoma

February 14th 2024

The BLA seeking the approval of denileukin diftitox in patients with relapsed/refractory cutaneous T-cell lymphoma was resubmitted to the FDA.

Unlocking the Potential: The Evolution of ADCs in HER2+ NSCLC

February 14th 2024

Joshua K. Sabari, MD, explains the utility of ADCs in patients with NSCLC and their benefit in patients with EGFR-, ALK-, or HER2-mutant disease.

ONC201 Looks to Prove Efficacy in Trial For Rare H3K27M-Mutated Diffuse Midline Gliomas

February 14th 2024

The dopamine receptor D2 antagonist ONC201 is under evaluation in patients with H3K27M-mutated diffuse midline glioma in the phase 3 ACTION trial.

The Ongoing Investigation of GLSI-100 Continues in the Flamingo-01 Study for HER2/Neu+ Breast Cancer

February 14th 2024

The ongoing Flamingo-01 trial continues to investigate GLSI-100 in HER2/neu-positive breast cancer following various holds.

FDA Grants Priority Review to Repotrectinib for NTRK+ Solid Tumors

February 14th 2024

Repotrectinib is under priority review for patients with NTRK-positive locally advanced or metastatic solid tumors and high unmet medical need.

Extending the Frontiers of Checkpoint Inhibition in Merkel Cell Carcinoma

February 14th 2024

In the treatment of unresectable or metastatic Merkel cell carcinoma, immune checkpoint inhibitors have activity and tolerability.

Recent Approvals Across Hematologic Malignancies Usher in a New Era

February 14th 2024

Mikkael A. Sekeres, MD, MS, highlights recent approvals and emerging therapeutics in hematologic malignancies discussed by his colleagues.

Standard-of-Care Drugs Provide Strong Foundation For Effective Combinations in Hematologic Malignancies

February 13th 2024

Catherine C. Coombs, MD, discusses future directions for BTK inhibitors in chronic lymphocytic leukemia and combination therapies in myelofibrosis.

McAndrew Expands on the Evolving Treatment Armamentarium in HER2+ Breast Cancer

February 13th 2024

Nicholas P. McAndrew, MD, MSCE, discusses how updated clinical trial findings are shifting the treatment paradigm in HER2-positive metastatic breast cancer.

FDA Approves Frontline NALIRIFOX for Metastatic Pancreatic Adenocarcinoma

February 13th 2024

The FDA has approved irinotecan liposome (Onivyde) with oxaliplatin, fluorouracil, and leucovorin, for the frontline treatment of metastatic pancreatic adenocarcinoma.

Rutgers Cancer Institute of New Jersey Unveils Leadership Enhancements for Next Era of Excellence

February 13th 2024

Rutgers Cancer Institute of New Jersey has elevated 2 associate director functions to deputy director positions.

FDA Grants Fast Track Designation to CAN-3110 for Recurrent High-Grade Glioma

February 13th 2024

CAN-3110, an HSV-1 oncolytic viral immunotherapy candidate, has received FDA fast track designation for adult patients with recurrent high-grade glioma.

FDA Accepts NDA Resubmission for Dasynoc in CML

February 13th 2024

A new drug application for Dasynoc, a protein kinase inhibitor product candidate for patients with chronic myeloid leukemia, has been accepted by the FDA.

APEX-01 Looks to Add First PSMA-Directed ADC to Treatment Paradigm in mCRPC

February 13th 2024

John Shen, MD, discusses the phase 1/2 APEX-01 trial of ARX517 in metastatic castration-resistant prostate cancer.

Long-Term CheckMate 238 Data Support Adjuvant Nivolumab Vs Ipilimumab in Resected Melanoma

February 13th 2024

Adjuvant nivolumab significantly improved relapse-free survival vs ipilimumab in resected stage III/IV melanoma, according to 7-year minimum follow-up.

FDA Grants Fast Track Designation to BXCL701 for Small Cell Neuroendocrine Prostate Cancer

February 12th 2024

BXCL701 has been granted fast track designation for select patients with metastatic small cell neuroendocrine prostate cancer by the FDA.

Emavusertib Demonstrates Safety, Early Antitumor Activity in Select Patients With FLT3-Mutant R/R AML

February 12th 2024

Alice Mims, MD, discusses the toxicity profile and initial efficacy of emavusertib in heavily pretreated, FLT3-mutated relapsed/refractory AML.

FELIX Pooled Analysis Findings Potentiate Further Obe-Cel Development in B-ALL

February 12th 2024

Michael R. Bishop, MD, discusses the rationale for and key findings from the FELIX trial of obe-cel in B-cell acute lymphoblastic leukemia.

NCCN Releases First Neuroblastoma Treatment Recommendations

February 12th 2024

The NCCN has published the first set of treatment recommendations for neuroblastoma.