Global Oncology | Specialty

The OncLive® Global Oncology condition center page is a comprehensive resource for clinical news and international expert insights on treatment of patients with cancer. This page features articles focused on ex-US regulatory news, interviews in written and video format, and podcasts that focus on unmet needs, treatment advances, and ongoing global research in oncology care.

Perioperative Serplulimab Meets Primary End Point of EFS in Gastric Cancer

October 11th 2025

Perioperative serplulimab plus chemotherapy significantly prolonged EFS vs placebo plus chemotherapy in gastric cancer.

ONO-4578 Plus Nivolumab/Chemo Improves PFS in HER2– Advanced Gastric Cancer

October 9th 2025

ONO-4578 plus nivolumab and chemotherapy improved PFS in HER2-negative advanced gastric cancer.

NICE Recommends First-Line Lorlatinib for Newly Diagnosed ALK+ NSCLC

October 7th 2025

Lorlatinib has received NICE’s recommendation for untreated advanced non–small cell lung cancer.

sNDA Submitted in Japan for T-DXd Plus Pertuzumab in HER2+ Advanced Breast Cancer

October 7th 2025

A new drug application was submitted to Japan’s Ministry of Health, Labour and Welfare for T-DXd plus pertuzumab for HER2-positive breast cancer.

OncLive’s September EMA Regulatory Recap: Key EU Approvals in Oncology

October 2nd 2025

Here is your snapshot of all oncologic therapeutic options that were approved by the EMA in September 2025.

A400/EP0031 NDA Accepted for Review in China for RET Fusion–Positive NSCLC

September 25th 2025

China’s NMPA has accepted for review a new drug application for A400/EP0031 in patients with RET fusion–positive non–small cell lung cancer.

INESSS Issues Positive Recommendation for the Reimbursement of Subcutaneous Nivolumab Across Solid Tumor Indications

September 23rd 2025

INESSS has issued a positive recommendation for the reimbursement of subcutaneous nivolumab across all Health Canada–authorized solid tumor indications.

Selumetinib Earns Positive CHMP Opinion for Adult NF1-Associated PNs

September 23rd 2025

CHMP has recommended the approval of selumetinib for symptomatic, inoperable plexiform neurofibromas (PNs) in adult neurofibromatosis type 1.

Vorasidenib Nets European Approval in IDH1/2-Mutated Grade 2 Glioma

September 22nd 2025

Vorasidenib has been approved by the European Commission for IDH1/2-mutated grade 2 glioma.

The OncFive: Top Oncology Articles for the Week of 9/14

September 20th 2025

The FDA held a Type A meeting for RP1 in advanced melanoma, the AACR released its Annual Cancer Progress Report, and more.

Taletrectinib Wins Japanese Approval for ROS1+ Advanced NSCLC

September 19th 2025

Taletrectinib was approved in Japan for advanced non–small cell lung cancer harboring ROS1 fusions.

Pembrolizumab Earns 2 Positive CHMP Opinions in HNSCC, Other EU Indications

September 19th 2025

The EMA’s CHMP has recommended the approval of subcutaneous pembrolizumab across all indications and perioperative pembrolizumab in locally advanced HNSCC.

CHMP Recommends EU Approval of Subcutaneous Mosunetuzumab in R/R Follicular Lymphoma

September 19th 2025

The CHMP has recommended the European approval of subcutaneous mosunetuzumab in relapsed/refractory follicular lymphoma.

European Commission Green-Lights Vimseltinib for Symptomatic, Unresectable TGCT

September 18th 2025

Vimseltinib earned approval from the European Commission for the treatment of symptomatic, unresectable tenosynovial giant cell tumors.

Optune Lua Secures Japanese Approval for Advanced NSCLC

September 17th 2025

Optune Lua plus concurrent PD-1/PD-L1 inhibition has been approved in Japan for advanced non–small cell lung cancer after platinum-based chemotherapy.

Histone Modification–Related Gene Signature Shows Prognostic Value in Multiple Myeloma

September 17th 2025

An HMR risk signature predicted outcomes in multiple myeloma, linked with genomic instability, immune microenvironment, and drug sensitivity.

KN026 NDA in Pretreated HER2+ Gastric or GEJ Cancer Accepted by NMPA for Review

September 17th 2025

The NDA seeking approval of KN026 plus chemotherapy in HER2-positive gastric or GEJ cancer has been accepted for review in China.

T-DXd Shows Real-World Efficacy in HER2+ and HER2-Low/Zero Breast Cancer Brain Metastases

September 16th 2025

T-DXd demonstrated durable systemic and intracranial responses in patients with HER2-positive, -low, and -zero breast cancer brain metastases.

Neoadjuvant Tislelizumab Plus Chemo Drives Responses in Locally Advanced Cervical Cancer

September 15th 2025

Neoadjuvant tislelizumab plus chemotherapy yielded responses in locally advanced cervical cancer.

Nadofaragene Firadenovec NDA Accepted for Review in Japan for BCG-Unresponsive NMIBC

September 15th 2025

A new drug application for nadofaragene firadenovec in BCG-unresponsive bladder cancer has been accepted for review in Japan.