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.

CHMP Recommends Subcutaneous Daratumumab Plus VRd for Newly Diagnosed Myeloma

February 28th 2025

The CHMP has recommend the approval of subcutaneous daratumumab plus VRd for newly diagnosed multiple myeloma.

CHMP Recommends Approval of Glofitamab Plus Chemotherapy for R/R DLBCL

February 28th 2025

CHMP has recommended glofitamab plus gemcitabine and oxaliplatin for R/R DLBCL.

Pirtobrutinib Earns Positive CHMP Opinion for R/R CLL After a Covalent BTK Inhibitor

February 28th 2025

The CHMP has recommended the European approval of pirtobrutinib for relapsed/refractory CLL previously treated with a covalent BTK inhibitor.

CHMP Recommends Conditional Approval of Linvoseltamab for R/R Multiple Myeloma

February 28th 2025

The CHMP has issued a positive opinion for linvoseltamab in relapsed/refractory multiple myeloma.

T-DXd Receives Positive CHMP Opinion for HER2-Low or HER2-Ultralow Metastatic Breast Cancer

February 28th 2025

The CHMP has recommended the approval of trastuzumab deruxtecan for HER2-low or HER2-ultralow metastatic breast cancer.

Ipilimumab Injection Plus Sintilimab Receives Priority Review in China for MSI-H/dMMR Colon Cancer

February 27th 2025

China’s NMPA has granted priority review to an NDA for neoadjuvant ipilimumab injection plus sintilimab in MSI-H or dMMR colon cancer.

Isatuximab Plus VRd Wins Japanese Approval for Newly Diagnosed Myeloma

February 25th 2025

Isatuximab plus VRd has been approved in Japan for transplant-ineligible, newly diagnosed multiple myeloma.

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.