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.

Epcoritamab Gains Japanese Approval for R/R Follicular Lymphoma

February 20th 2025

The Ministry of Health, Labour, and Welfare in Japan has approved epcoritamab for relapsed or refractory follicular lymphoma.

Denosumab Biosimilars Win FDA, EU Approvals for Select Cancer-Related Bone Loss

February 17th 2025

The FDA and European Commission have approved 2 biosimilars referencing denosumab for cancer-related bone loss and other indications.

Illuccix PSMA-PET Imaging Agent Receives UK Approval in Prostate Cancer

February 13th 2025

The UK Medicines and Healthcare Products Regulatory Agency has approved the kit for the preparation of gallium-68 gozetotide injection.

ATG-022 Demonstrates Safety, Preliminary Efficacy in Advanced CLDN18.2+ Gastric Cancer

February 6th 2025

Phase 1 study data demonstrated that ATG-022 has a manageable safety profile and produced activity in patients with gastric cancer and CLDN 18.2 expressions.

Serplulimab Plus Chemotherapy Wins EU Approval for Treatment-Naive ES-SCLC

February 5th 2025

The European Commission has approved serplulimab in combination with carboplatin and etoposide for the frontline treatment of adult patients with ES-SCLC.

Subcutaneous Amivantamab Nears EU Approval in Advanced EGFR+ NSCLC

February 4th 2025

The EMA’s CHMP has issued a positive opinion supporting the approval of subcutaneous amivantamab in EGFR-mutated NSCLC.

CHMP Recommends Approval of Durvalumab for Limited-Stage Small Cell Lung Cancer

February 3rd 2025

The CHMP has recommended approval for durvalumab in limited-stage small cell lung cancer following platinum-based chemoradiation.

Datopotamab Deruxtecan Wins CHMP Positive Opinion for Previously Treated HR+ Breast Cancer

January 31st 2025

Datopotamab deruxtecan approaches approval in Europe as an option for patients with previously treated hormone receptor–positive breast cancer.

Nivolumab/Ipilimumab Approaches EU Approval in Unresectable or Advanced HCC

January 31st 2025

The EMA’s CHMP has adopted a positive opinion regarding frontline nivolumab plus ipilimumab in unresectable or advanced hepatocellular carcinoma.

China's NMPA Approves Isatuximab Plus VRd for Newly Diagnosed, Transplant-Ineligible Myeloma

January 31st 2025

China’s NMPA approved isatuximab plus VRd for newly diagnosed, transplant-ineligible multiple myeloma.

Liso-Cel Earns CHMP Recommendation for R/R Follicular Lymphoma

January 31st 2025

The EMA’s CHMP has recommended the approval of liso-cel for relapsed/refractory follicular lymphoma after at least 2 prior lines of therapy.

European Commission Approves Blinatumomab Consolidation in Newly Diagnosed CD19+ B-ALL

January 30th 2025

The European Commission has approved blinatumomab as consolidation therapy for Ph-negative, CD19-postive B-cell precursor acute lymphoblastic leukemia.

Fruquintinib Plus TAS-102 Demonstrates Efficacy and Acceptable Toxicity in Pretreated mCRC

January 27th 2025

Updated phase 2 data revealed fruquintinib plus TAS-102 could offer survival benefits in pretreated metastatic colorectal cancer.

Nogapendekin Alfa Inbakicept Is Under EMA Review for BCG-Unresponsive NMIBC With CIS

January 27th 2025

The EMA has accepted for review an MAA seeking the approval of nogapendekin alfa inbakicept plus BCG for BCG-unresponsive NMIBC with CIS.

Isatuximab Plus VRd Wins EU Approval for Newly Diagnosed, Transplant-Ineligible Multiple Myeloma

January 22nd 2025

The EMA’s CHMP has approved isatuximab in combination with VRd for transplant-ineligible patients with newly diagnosed multiple myeloma.

First-Line Amivantamab Plus Lazertinib Wins EU Approval for EGFR+ Advanced NSCLC

January 21st 2025

The European Commission approved first-line amivantamab plus lazertinib for EGFR-mutated advanced non–small cell lung cancer.

Rapid, At-Home PSA Screening Test Gains Approval in UAE for Early Detection of Prostate Cancer

January 21st 2025

The Fortel PSA Screening Test has been approved by the United Arab Emirates MOHAP for the rapid detection of early signs of prostate cancer.

Health Canada Green Lights Fruquintinib for Metastatic Colorectal Cancer

January 20th 2025

Health Canada approved fruquintinib for select patients with metastatic colorectal cancer.

European Commission Approves Dostarlimab Plus Chemo for All Advanced/Recurrent Endometrial Cancer

January 20th 2025

Frontline dostarlimab plus chemotherapy has been approved in the EU for all adult patients with primary advanced or recurrent endometrial cancer.

Senaparib Receives NMPA Approval As First-Line Maintenance in Ovarian Cancer

January 17th 2025

Senaparib has received marketing authorization in China as a first-line maintenance therapy for advanced ovarian cancer.