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 Accepts Marketing Application for T-DXd in HER2-Low and -Ultralow Metastatic Breast Cancer

August 19th 2024

The EMA has validated a type II variation application for trastuzumab deruxtecan for select patients with HER2-low or -ultralow metastatic breast cancer.

EMA Validates Application for Liso-Cel in Relapsed/Refractory Follicular Lymphoma

August 19th 2024

The EMA has expanded the indication for lisocabtagene maraleucel to include the treatment of patients with relapsed or refractory follicular lymphoma.

Ivonescimab Under Priority Review by China’s NMPA for Frontline PD-L1–Positive NSCLC

August 15th 2024

Ivonescimab has been granted priority review in China for the frontline treatment of patients with PD-L1–positive locally advanced or metastatic NSCLC.

Dr Trudel on the Significance of the DREAMM-7 and DREAMM-8 Trials in R/R Multiple Myeloma

August 15th 2024

Suzanne Trudel, MSc, MD, discusses the implications of results from the DREAMM-7 and DREAMM-8 trials in relapsed/refractory multiple myeloma.

Durvalumab-Based Combos Win EU Approval for Advanced/Recurrent Endometrial Cancer

August 14th 2024

Durvalumab plus chemotherapy, then durvalumab with or without olaparib, was approved in Europe for select advanced/recurrent endometrial cancer.

Dr Bertossi on the Role of Centralized Academic Reference Diagnostics and Biobanking in Clinical Trials

August 14th 2024

Consuelo Bertossi, MD, discusses centralized academic reference diagnostics and biobanking in prospective, multicenter clinical trials.

T-DXd Wins Conditional Approval in China for Pretreated HER2+ Gastric/GEJ Cancer

August 13th 2024

Trastuzumab deruxtecan earned conditional approval in China for HER2-positive gastric/gastroesophageal junction cancer after at least 2 lines of therapy.

Toripalimab sNDA Under Review in China for Frontline Unresectable or Metastatic Melanoma

August 13th 2024

A sNDA seeking the approval of toripalimab for frontline use in patients with unresectable or metastatic melanoma is under review by the NMPA.

China’s NMPA Grants Breakthrough Therapy Designation to 9MW2821 in Advanced Urothelial Cancer

August 12th 2024

The Nectin-4–directed antibody-drug conjugate 9MW2821 has received breakthrough therapy designation in China for pretreated, advanced urothelial carcinoma.

Trastuzumab Deruxtecan Demonstrates Activity in HER2-Expressing Biliary Tract Cancer

August 10th 2024

Trastuzumab deruxtecan elicited responses in patients with HER2-positive biliary tract cancer, according to data from a single-arm, phase 2 trial.

Bevacizumab Biosimilar Receives Approval in the European Union

July 30th 2024

The European Medicines Agency has approved Avzivi, a biosimilar referencing bevacizumab.

China’s NMPA Accepts sBLA for Ivonescimab in First-Line PD-L1+ NSCLC

July 29th 2024

China’s NMPA has accepted an sBLA for ivonescimab in first-line, PD-L1–positive non–small cell lung cancer.

CHMP Recommends Toripalimab Plus Chemo for Metastatic Nasopharyngeal Carcinoma and Advanced ESCC

July 29th 2024

The EMA’s CHMP has recommended toripalimab plus chemotherapy for metastatic nasopharyngeal carcinoma and advanced esophageal squamous cell carcinoma.

Zolbetuximab Plus Chemo Approaches EU Approval for Advanced Gastric/GEJ Cancer

July 26th 2024

The EMA's CHMP has recommended zolbetuximab plus chemotherapy in select locally advanced unresectable or metastatic HER2-negative gastric or GEJ cancer.

CHMP Recommends Amivantamab Plus Chemo for Pretreated EGFR+ Advanced NSCLC

July 26th 2024

The EMA’s CHMP has recommended the approval of amivantamab plus chemotherapy for pretreated, EGFR-mutated advanced non–small cell lung cancer.

First-Line Sugemalimab Plus Chemo Wins European Approval for Metastatic NSCLC

July 26th 2024

First-line sugemalimab plus chemotherapy has been approved in Europe for metastatic non–small cell lung cancer.

Pembrolizumab Plus Enfortumab Vedotin Earns CHMP Recommendation in Frontline Metastatic Urothelial Carcinoma

July 26th 2024

The CHMP has recommended pembrolizumab plus enfortumab vedotin-ejfv in frontline unresectable or metastatic urothelial carcinoma.

NICE Recommends Pembrolizumab Plus Chemo for Untreated HER2– Advanced Gastric/GEJ Adenocarcinoma

July 26th 2024

NICE recommends pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for untreated HER2-negative advanced gastric or GEJ adenocarcinoma.

Dr Facon on the Implications of Isatuximab Plus VRd in Transplant-Ineligible Newly Diagnosed Myeloma

July 25th 2024

Thierry Facon, MD, discusses clinical implications from the phase 3 IMROZ trial

EU Approval Sought for Vimseltinib in Tenosynovial Giant Cell Tumor

July 19th 2024

The marketing authorization application seeking the approval of vimseltinib for the treatment of tenosynovial giant cell tumor is under EMA review.