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.

EMA Validates MAA for Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

February 2nd 2024

The MAA seeking the approval of tisotumab vedotin in select patients with recurrent or metastatic cervical cancer has been validated by the EMA.

EMA Accepts Marketing Authorization Application for Linvoseltamab in R/R Multiple Myeloma

February 2nd 2024

The EMA has accepted for review an MAA seeking the approval of linvoseltamab for use in select patients with relapsed/refractory multiple myeloma.

Japanese Approval Sought for Enfortumab Vedotin Plus Pembrolizumab in Urothelial Cancer

February 1st 2024

A sNDA seeking approval of enfortumab vedotin plus pembrolizumab for first-line use in patients with urothelial cancer has been submitted to Japan’s MHLW.

Momelotinib Approved in Europe for Myelofibrosis With Anemia

January 29th 2024

Momelotinib gets market authorization from the European Commission for patients with MPNs and disease-related splenomegaly or moderate to severe anemia.

Idecabtagene Vicleucel Approaches EU Approval in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma

January 26th 2024

The EMA's CHMP has recommended the approval of idecabtagene vicleucel in patients with multiple myeloma who received at least 2 prior therapies.

Olverembatinib Added to NCCN Guidelines for CML

January 22nd 2024

Olverembatinib has been added to the NCCN's latest 2024 guidelines for management of chronic myeloid leukemia.

NICE Recommends Talazoparib for Advanced BRCA1/2-Mutant, HER2– Breast Cancer

January 22nd 2024

NICE has recommended talazoparib for the treatment of patients with advanced or metastatic HER2-negative breast cancer with germline BRCA1/2 mutations.

Dr Shitara on the 4-Year Outcomes of the CheckMate 649 Trial in GEJ Adenocarcinoma

January 20th 2024

Kohei Shitara, MD, discusses first-line nivolumab plus chemotherapy vs chemotherapy alone in gastric cancer, GEJ cancer, or esophageal adenocarcinoma.

Dr Lencioni on the Results of the EMERALD-1 Trial in Unresectable HCC

January 19th 2024

Riccardo Lencioni, MD, FSIR, EB, discusses the EMERALD-1 trial of TACE/durvalumab/bevacizumab in patients with unresectable hepatocellular carcinoma.

Dr Powles on the Efficacy of Enfortumab Vedotin Plus Pembrolizumab in Metastatic Urothelial Cancer

January 16th 2024

Thomas Powles, MD, MBBS, MRCP, discusses the use of enfortumab vedotin plus pembrolizumab in urothelial carcinoma based on data from the KEYNOTE-A39 trial.

European Commission Approves Subcutaneous Atezolizumab With Enhanze for Several Cancers

January 16th 2024

The European Commission granted marketing authorization for SC atezolizumab co-formulated with Enhanze for all approved indications of IV atezolizumab.

EMA Grants Orphan Drug Designation to Pimicotinib for Inoperable TGCT

January 15th 2024

The European Medicines Agency has granted orphan drug designation to pimicotinib for use in patients with inoperable tenosynovial giant cell tumor.

EU Approval Sought for Frontline Lazertinib Plus Amivantamab in EGFR+ NSCLC

January 15th 2024

An MAA seeking the approval of lazertinib plus amivantamab in the first-line treatment of adult patients with EGFR+ NSCLC has been submitted to the EMA.

NMPA Accepts and Grants Priority Review to NDA for Sovleplenib in Primary Immune Thrombocytopenia

January 11th 2024

The China National Medical Products Administration has accepted the NDA seeking approval of sovleplenib in patients with primary immune thrombocytopenia.

Adagrasib Approved in Europe for Pretreated KRAS G12C+ Advanced NSCLC

January 10th 2024

The European Commission has granted conditional marketing authorization to adagrasib for patients with KRAS G12C+ advanced non–small cell lung cancer.

NMPA Approval Sought for Frontline Cadonilimab Plus Chemo in Gastric or GEJ Adenocarcinoma

January 8th 2024

China’s NMPA has accepted the sNDA seeking the approval of cadonilimab plus chemotherapy for use in select patients with gastric or GEJ adenocarcinomas.

Dr Bartsch on the TUXEDO-1 Trial of T-DXd in HER2+ Breast Cancer With Brain Metastases

January 5th 2024

Rupert Bartsch, MD, discusses findings from the final analysis of the phase 2 TUXEDO-1 trial of trastuzumab deruxtecan in patients with HER2-positive breast cancer with active brain metastases.

EMA Validates MAA for Repotrectinib in ROS1+ NSCLC and NTRK+ Solid Tumors

January 3rd 2024

The European Medicines Agency has validated its marketing authorization application for repotrectinib in adult patients with ROS1 TKI-naive or -pretreated locally advanced or metastatic non–small cell lung cancer harboring ROS1 fusions, as well as adult and pediatric patients with TKI-naive and pretreated NTRK-positive locally advanced or metastatic solid tumors.

Sugemalimab Plus Chemo Receives Approval in China for Esophageal Squamous Cell Carcinoma

January 2nd 2024

The National Medical Products Administration of China has approved sugemalimab paired with fluorouracil and platinum-based chemotherapy for use in the frontline treatment of patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

European Commission Approves New Frontline Indications for Pembrolizumab Plus Chemo in Select GI Cancers

December 21st 2023

The European Commission has approved new indications for pembrolizumab in combination with chemotherapy in select patients with gastric or gastroesophageal adenocarcinoma and select patients with biliary tract cancer.