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.

Ventana Assay Earns CE IVDR Approval in EU as Companion Diagnostic in HER2-Expressing Breast and Biliary Tract Cancers

September 5th 2025

The VENTANA HER2 (4B5) test earned CE-IVDR approval in Europe to assess HER2 status in metastatic breast cancer and biliary tract cancer.

VAX014 Demonstrates Safety, Early Signs of Immune-Mediated Activity in Advanced Solid Tumors

September 5th 2025

Chemoradiotherapy Data, PCI Controversy, and Translational Research Advance SCLC Care

September 5th 2025

Misty D. Shields, MD, PhD, discusses the inefficacy of concurrent immunotherapy and chemoradiation in lung cancer and the debate surrounding PCI in SCLC.

Lunresertib and Other PKMYT1 Inhibitors Show Promise in Gynecologic Malignancies

September 5th 2025

Alison Schram, MD, discusses the potential clinical utility of PKMYT1-targeted agents in gynecologic malignancies.

Ziftomenib With 7+3 Shows Early Promise in Newly Diagnosed NPM1-Mutated/KMT2A-Rearranged AML

September 4th 2025

The combination of ziftomenib and cytarabine/daunorubicin showed a manageable safety profile with early efficacy in NPM1-mutated and KMT2A-rearranged AML.

Peak CAR T-Cell Expansion Associated With Reduced Relapse Risk Following Brexu-Cel Consolidation in B-ALL

September 4th 2025

Favorable long-term outcomes were reported with brexu-cel in patients with B-ALL and low disease burden who achieved peak CAR T-cell expansion.

Zanubrutinib Extends PFS vs Acalabrutinib Plus Venetoclax in Untreated, Low-Risk CLL

September 4th 2025

Zanubrutinib bested acalabrutinib plus venetoclax in terms of PFS in patients with treatment-naive, low-risk CLL.

Meta-Analysis Highlights Efficacy, Safety Benefits With Asciminib in Chronic Myeloid Leukemia

September 4th 2025

Findings from a meta-analysis associated asciminib with improved efficacy and safety vs other TKIs in chronic myeloid leukemia.

Venetoclax Plus Azacitidine Fails to Provide OS Advantage in Treatment-Naive, Higher-Risk MDS

September 4th 2025

First-line venetoclax plus azacitidine did not improve overall survival vs placebo plus azacitidine in treatment-naive, higher-risk MDS.

Zanubrutinib Prolongs PFS, Shows Trend Toward Improved OS in MAIC Analysis in CLL

September 4th 2025

Continuous zanubrutinib improved PFS and showed a trend for improved OS vs fixed-duration venetoclax-based therapy in treatment-naive CLL/SLL.

Olutasidenib Monotherapy Yields Responses in Primary Refractory IDH1-Mutant AML

September 4th 2025

A post hoc analysis demonstrated the efficacy of olutasidenib monotherapy in primary refractory patients with IDH1-mutant AML.

Olomorasib Plus Pembrolizumab Earns Breakthrough Therapy Designation in Untreated KRAS G12C–Mutated NSCLC

September 4th 2025

Olomorasib plus pembrolizumab has been granted breakthrough therapy designation by the FDA in first-line KRAS G12C–mutated NSCLC.

Zongertinib Receives FDA Breakthrough Therapy Designation in Nonsquamous NSCLC With HER2 TKD Mutations

September 4th 2025

The FDA has granted breakthrough therapy designation to zongertinib in the first line for nonsquamous NSCLC harboring HER2 TKD activating mutations.

Roswell Park Study Reveals New Clues to Pancreatic Cancer Spread—and a Possible Way to Stop It

September 4th 2025

Findings suggest that treatment with an FGFR4 inhibitor can disrupt tumor spread in pancreatic cancer.

Liquid Formulations of Oncologic Agents Improves Dosing Consistency, Treatment Adherence in Patients With Dysphagia

September 4th 2025

Christopher Phillips, PharmD, discusses the advantages of liquid drug formulations over tablets and capsules for select pediatric or adult patients with cancer.

Tisotumab Vedotin Approved in Hong Kong for Recurrent or Metastatic Cervical Cancer

September 3rd 2025

Tisotumab vedotin is cleared in Hong Kong for the treatment of select patients with cervical cancer.

GD2-Directed CAR T-Cell Therapy Generates Early Antitumor Activity in H3K27M-Mutant Diffuse Midline Glioma

September 3rd 2025

Michelle Monje, MD, PhD, highlights early efficacy data with a GD2-directed CAR T-cell therapy for H3K27M-mutant diffuse midline gliomas.

Shorter, Less Intense Radiation-Chemo Regimen Effective for HPV-Linked Oropharyngeal Cancer, Mayo Study Shows

September 3rd 2025

A shorter and less intense course of postoperative radiation plus chemotherapy was shown to be effective in HPV-positive oropharyngeal cancer.

EU Approves MMR IHC Panel pharmDx as a Companion Diagnostic for Nivolumab/Ipilimumab in MSI-H/dMMR CRC

September 3rd 2025

The MMR IHC Panel pharmDx was certified in the EU as a companion diagnostic to identify patients with colorectal cancer eligible for nivolumab/ipilimumab.

Health Canada Approves Mirvetuximab Soravtansine for FRα+ Platinum-Resistant Epithelial Ovarian Cancer

September 3rd 2025

Health Canada approved mirvetuximab soravtansine for folate receptor-alpha positive, platinum-resistant epithelial ovarian cancer.