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.

European Commission Approves First-Line Tislelizumab Plus Chemo for Metastatic Nasopharyngeal Carcinoma

July 10th 2025

The European Commission has approved tislelizumab plus gemcitabine/cisplatin for adults with recurrent or metastatic nasopharyngeal carcinoma.

Bexobrutideg Earns EMA Orphan Drug Designation for Waldenström Macroglobulinemia

July 9th 2025

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

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.

EU Approval Is Sought for Niraparib/Abiraterone Acetate Dual-Action Tablet in mHSPC With HRR Gene Alterations

July 7th 2025

European approval is being sought for the combination of niraparib, abiraterone acetate, and prednisone or prednisolone for HRR-mutated mHSPC.

Nivolumab/Ipilimumab Maintains OS, ORR Benefits in Chinese Patients With Unresectable HCC

July 4th 2025

Nivolumab plus ipilimumab maintained an ORR benefit across subgroups of Chinese patients with unresectable hepatocellular carcinoma.

Denosumab Biosimilar Earns European Approval in Advanced Malignancies Involving the Bone and Giant Cell Tumors of the Bone

July 2nd 2025

Denbrayce was approved in Europe for the treatment of skeletal-related events in advanced malignancies involving the bone and giant cell tumor of the bone.

CHMP Provides Positive Opinion for MRD Negativity as an End Point for Regulatory Myeloma Clinical Trials

July 2nd 2025

The EMA’s CHMP has issued a positive opinion for the use of MRD-negative CR as an end point for regulatory clinical trials for patients with myeloma.

Zanidatamab Nets European Approval in Pretreated HER2+ Biliary Tract Cancer

July 1st 2025

Zanidatamab has become the first HER2-targeted agent to gain conditional approval for HER2-positive biliary tract cancer in the European Union.

China NMPA Approves Savolitinib Plus Osimertinib for EGFR-Mutant, MET-Amplified NSCLC

June 30th 2025

China’s NMPA approved savolitinib plus osimertinib for EGFR-mutant NSCLC with MET amplification after progression on prior EGFR TKI therapy.

Satri-Cel NDA Gets Go-Ahead From NMPA in Pretreated CLDN18.2+ Advanced Gastric/GEJ Cancer

June 26th 2025

The NMPA of China has accepted the new drug application for satricabtagene autoleucel in pretreated gastric/GEJ cancer.

Serplulimab Earns UK Approval for First-Line ES-SCLC

June 24th 2025

Serplulimab is now the only anti–PD-1 monoclonal antibody approved by the MHRA for patients with extensive-stage small cell lung cancer in the first line.

CHMP Recommends Isatuximab Plus VRd for Transplant-Eligible, Newly Diagnosed Myeloma

June 23rd 2025

CHMP issues positive opinion for isatuximab plus VRd in transplant-eligible, newly diagnosed multiple myeloma.

Subcutaneous Daratumumab Approaches EU Approval in High-Risk Smoldering Myeloma

June 20th 2025

The EMA’s CHMP has issued a positive opinion regarding the use of subcutaneous daratumumab in high-risk smoldering myeloma.

UM171 Cell Therapy Earns Positive CHMP Opinion for Hematological Malignancies

June 20th 2025

The EMA’s CHMP has issued a positive opinion for UM171 cell therapy for patients with hematological malignancies and limited stem cell transplant options.

Darolutamide Plus ADT Earns Positive Opinion for European Approval From CHMP in Metastatic Hormone-Sensitive Prostate Cancer

June 20th 2025

The European Medicines Agency’s CHMP has recommended the approval of darolutamide plus ADT in mHSPC in the European Union.

Nirogacestat Awaits Review Following Positive CHMP Opinion for Desmoid Tumors

June 20th 2025

The EMA’s Committee for Medicinal Products for Human Use granted a positive opinion for nirogacestat for the treatment of patients with desmoid tumors.

CHMP Recommends EU Approval of Cabozantinib for Pancreatic and Extra-Pancreatic Neuroendocrine Tumors

June 20th 2025

The EMA’s CHMP has recommended the approval of cabozantinib for patients with pancreatic and extra-pancreatic neuroendocrine tumors.

CHMP Recommends Ibrutinib Plus Chemoimmunotherapy for Frontline, Transplant-Eligible Mantle Cell Lymphoma

June 20th 2025

CHMP recommended ibrutinib plus immunochemotherapy for previously untreated, transplant-eligible mantle cell lymphoma.

Health Canada Approves Adjuvant Ribociclib for HR+/HER2– Early Breast Cancer

June 19th 2025

Adjuvant ribociclib plus endocrine therapy has gained Canadian approval for HR-positive/HER2-negative early breast cancer at high risk of recurrence.