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.

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.

Ide-Cel Wins Japanese Approval in Early Relapsed/Refractory Multiple Myeloma

December 14th 2023

Idecabtagene vicleucel has received marketing and manufacturing approval in Japan for its supplemental new drug application in patients with relapsed/refractory multiple myeloma who have received at least 2 prior lines of therapy.

Axatilimab Elicits Responses With Manageable Safety in Recurrent/Refractory cGVHD

December 11th 2023

Axatilimab induced rapid and durable responses with an acceptable toxicity profile at all doses analyzed with highest efficacy observed at the 0.3-mg/kg dose in patients with recurrent or refractory chronic graft-vs-host disease.

EMA Validates Application for Epcoritamab in Relapsed/Refractory Follicular Lymphoma

November 27th 2023

The European Medicines Agency has validated a type II application for the investigational T-cell engaging bispecific antibody epcoritamab-bysp for patients with relapsed/refractory follicular lymphoma following at least 2 prior lines of therapy

Taletrectinib Under NMPA Review in China for Advanced or Metastatic ROS1+ NSCLC

November 22nd 2023

The Center for Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application seeking the approval of the next-generation ROS1 TKI taletrectinib for the treatment of patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer with prior exposure to a ROS1 TKI.

Sugemalimab Receives Approval in China for Relapsed/Refractory Extranodal NK/T-cell Lymphoma

November 22nd 2023

The National Medical Products Administration of China has approved sugemalimab for use in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma.

Rucaparib Receives EC Approval for Advanced Ovarian Cancer

November 20th 2023

The European Commission has approved rucaparib as first-line maintenance therapy for patients with advanced ovarian cancer, regardless of BRCA mutation status, who have responded following the completion of frontline platinum-based chemotherapy.

Zanubrutinib Plus Obinutuzumab Gets EU Approval for R/R Follicular Lymphoma

November 17th 2023

The European Commission has granted marketing authorization to the combination of zanubrutinib and obinutuzumab for the treatment of adult patients with relapsed/refractory follicular lymphoma following at least 2 prior lines of systemic therapy.

Vebreltinib Receives Approval in China For MET Exon 14+ NSCLC

November 16th 2023

China’s National Medical Products Administration has granted conditional marketing approval to vebreltinib for the treatment of patients with non–small cell lung cancer harboring MET exon 14 skipping mutations.

Durvalumab Plus Chemo Wins Approval in China For Advanced/Metastatic Biliary Tract Cancer

November 14th 2023

China’s National Medical Products Administration has approved durvalumab plus gemcitabine and cisplatin for frontline use in adult patients with locally advanced or metastatic biliary tract cancer.