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 EU Approval of Zanidatamab for HER2+ Advanced Biliary Tract Cancer

April 25th 2025

The EMA’s CHMP issued a positive opinion for zanidatamab in previously treated HER2-positive biliary tract cancer.

CHMP Recommends Brentuximab Vedotin Plus ECADD for Newly Diagnosed Stage IIB/III/IV Hodgkin Lymphoma

April 25th 2025

The EMA’s CHMP has recommended the approval of brentuximab vedotin plus ECADD for newly diagnosed, stage IIB/III/IV Hodgkin lymphoma.

Orelabrutinib Wins Approval in China for First-Line CLL and SLL

April 25th 2025

China’s NMPA has approved orelabrutinib for the first-line treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma.

China’s NMPA Approves Toripalimab in First-Line Melanoma

April 25th 2025

China’s NMPA has approved the sNDA for toripalimab as a first-line treatment for patients with unresectable or metastatic melanoma.

Japanese Approval Is Sought for T-DXd in HER2+ Advanced Solid Tumors

April 24th 2025

Japan’s Ministry of Health has received a supplemental new drug application for T-DXd for HER2-positive advanced or recurrent solid tumors.

Optune Lua Granted CE Mark Approval in EU for Metastatic NSCLC

April 24th 2025

A CE Mark has been granted to Optune Lua concurrent with immune checkpoint inhibitors or docetaxel for patients with metastatic non–small cell lung cancer.

Extended Adjuvant Pyrotinib Shows Promising Efficacy After Trastuzumab-Based Therapy in HER2+ Breast Cancer

April 23rd 2025

Pyrotinib led to high 2-year iDFS rates in the adjuvant setting following adjuvant trastuzumab-based treatment in HER2-positive breast cancer.

First-Line Ivonescimab Plus Chemo Improves PFS in Advanced Squamous NSCLC

April 23rd 2025

Ivonescimab plus chemotherapy met the primary PFS end point vs tislelizumab plus chemotherapy in advanced squamous NSCLC.

Inati-Cel Induces High CR and MRD Negativity Rates in CD19+ R/R B-ALL

April 23rd 2025

Inati-cel generated complete remissions and MRD negativity in CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.

Nadofaragene Firadenovec Yields High 3-Month CR Rates in High-Risk BCG-Unresponsive NMIBC With CIS

April 22nd 2025

Nadofaragene firadenovec was safe and produced high CR rates at 3 months in Japanese patients with high-risk BCG-unresponsive NMIBC and CIS.

Health Canada Approves Pembrolizumab/Chemotherapy for Unresectable, Advanced or Metastatic Pleural Mesothelioma

April 22nd 2025

Pembrolizumab/chemotherapy was approved by Health Canada for the treatment of patients with unresectable advanced or metastatic pleural mesothelioma.

China’s NMPA Accepts sNDA for Repotrectinib for NTRK+ Solid Tumors

April 21st 2025

China’s NMPA has accepted an sNDA for review, seeking the approval of repotrectinib for advanced solid tumors harboring NTRK fusions.

Dostarlimab/Chemo Earns Expanded Canadian Approval in Primary Advanced, First Recurrent Endometrial Cancer

April 18th 2025

Dostarlimab/chemotherapy was granted an expanded approval by Health Canada to treat patients with primary advanced or first recurrent endometrial cancer.

Global Analysis Shows Significant Variability in Sarcoma Clinical Trial Availability

April 18th 2025

High variability in sarcoma clinical trial funding, location, and phase was identified in a global analysis conducted over the past decade.

Belantamab Mafodotin–Based Combos Win UK Approval for R/R Myeloma

April 17th 2025

Two belantamab mafodotin–based combinations have been approved in the United Kingdom for relapsed/refractory multiple myeloma.

Companion Diagnostic Nets European IVDR Certification for Pembrolizumab Eligibility in Gastric/GEJ Adenocarcinoma

April 17th 2025

The PD-L1 IHC 22C3 pharmDx assay has been granted European IVDR certification for identifying pembrolizumab eligibility in gastric/GEJ adenocarcinoma.

NDA Accepted in China for Zurletrectinib for NTRK Gene Fusion+ Advanced Solid Tumors

April 16th 2025

A new drug application for zurletrectinib has been accepted in China for the treatment of patients with NTRK gene fusion–positive advanced solid tumors.

BTK Inhibitor Refractoriness and Platelet Count Are Prognostic for Survival With Brexu-Cel in MCL

April 14th 2025

Patients with MCL who received real-world brexu-cel experienced lower survival when they were BTK inhibitor refractory and/or had lower platelet counts.

Glofitamab Plus Chemo Wins European Approval for R/R DLBCL

April 14th 2025

The EC approved glofitamab with gemcitabine/oxaliplatin for patients with relapsed or refractory diffuse large B-cell lymphoma, ineligible for ASCT.

Health Canada Approves Durvalumab Monotherapy for Limited-Stage Small Cell Lung Cancer

April 11th 2025

Durvalumab received approval from Health Canada for patients with LS-SCLC whose disease has not progressed after platinum-based chemoradiation.