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.

Frontline Nivolumab/Chemo Approved in Europe for Unresectable or Metastatic Urothelial Cancer

May 29th 2024

The European Commission approved nivolumab plus cisplatin and gemcitabine for first-line treatment in unresectable or metastatic urothelial carcinoma.

EMA Validates Filings for Denosumab Biosimilar Candidate HLX14 for Osteoporosis

May 24th 2024

Marketing authorization applications for the denosumab biosimilar HLX14 have been validated by the EMA.

Dr Shitara on the Background of the CheckMate 649 Trial in GEJ Adenocarcinoma

May 22nd 2024

Kohei Shitara, MD, discusses the background of the phase 3 CheckMate 649 study in advanced gastric cancer, GEJ cancer, and esophageal adenocarcinoma.

European Commission Approves Two Denosumab Biosimilars

May 22nd 2024

Two biosimilars for reference denosumab have received marketing authorization from the European Commission.

Olaparib/Durvalumab/Fulvestrant Combo Meets PFS End Point in HRR-Altered or MSI ER+/HER2– Breast Cancer

May 15th 2024

Olaparib, durvalumab, and fulvestrant produced a 66.7% 24-week PFS rate in patients with endocrine-resistant, ER-positive, HER2-negative breast cancer.

Frontline Atezolizumab Plus Sacituzumab Govitecan Elicits Responses in PD-L1+ Advanced TNBC

May 15th 2024

First-line atezolizumab plus sacituzumab govitecan led to responses in PD-L1–positive locally advanced or metastatic triple-negative breast cancer.

Repotrectinib Receives NMPA Approval in China for ROS1+ NSCLC

May 13th 2024

Repotrectinib has been approved by China’s National Medical Products Administration for the treatment of patients with ROS1-positive NSCLC.

NICE Recommends Oncotype DX for Guiding Chemotherapy Decisions in Early-Stage, HR+/HER2– Breast Cancer

May 10th 2024

NICE recommends Oncotype DX to guide chemotherapy decisions in early-stage, HR-positive, HER2-negative breast cancer involving up to 3 positive nodes.

IBI343 Receives Breakthrough Therapy Designation in China for Claudin 18.2+ Advanced Gastric/GEJ Cancer

May 8th 2024

China's NMPA has granted breakthrough therapy designation to IBI343 for use in select patients with claudin 18.2–positive gastric or GEJ adenocarcinoma.

Health Canada Approves Goserelin Acetate for High-Risk, ER+ Early and Advanced Breast Cancer

May 8th 2024

Health Canada has approved an sNDA for goserelin acetate 10.8 mg every 12 weeks for ER-positive early breast cancer with a high risk of recurrence or advanced breast cancer.

EMA Validates MAA for Frontline Nivolumab/Ipilimumab for MSI-H/dMMR mCRC

May 6th 2024

The European Medicines Agency has validated an application for nivolumab plus ipilimumab for frontline MSI-H/dMMR metastatic colorectal cancer.

NXC-201 Receives Orphan Drug Designation in the European Union for Multiple Myeloma

May 3rd 2024

The CAR T-cell therapy NXC-201 has received orphan drug designation from the European Commission for patients with multiple myeloma.

Chidamide Plus R-CHOP Approved in China for MYC/BCL2–Expressing DLBCL

April 30th 2024

Chidamide plus R-CHOP has received approval from China’s NMPA for the management of diffuse large B-cell lymphoma.

CHMP Recommends Capivasertib/Fulvestrant for Pretreated ER+/HER2– Advanced Breast Cancer With PIK3CA, AKT1, or PTEN Alterations

April 29th 2024

The EMA’s CHMP recommended capivasertib/fulvestrant for ER-positive, HER2-negative advanced breast cancer harboring PIK3CA, AKT1, or PTEN alterations.

Frontline Amivantamab Plus Chemo Receives Positive EU CHMP Opinion for EGFR Exon 20 Insertion+ NSCLC

April 26th 2024

Frontline amivantamab with chemotherapy has been recommended for approval by the CHMP in EGFR exon 20 insertion+ non–small cell lung cancer.

CHMP Recommends Frontline Nivolumab Plus Chemo in Unresectable/Metastatic Urothelial Carcinoma

April 26th 2024

Frontline nivolumab plus chemotherapy has been recommended for approval in unresectable or metastatic urothelial carcinoma.

Fruquintinib Receives Positive CHMP Opinion for Previously Treated mCRC

April 26th 2024

CHMP has voiced its support for the approval of fruquintinib in previously treated metastatic colorectal cancer.

Vebreltinib Receives NMPA Approval in China for MET Fusion+ Glioma

April 25th 2024

Vebreltinib has received approval from China’s NMPA in pretreated IDH-mutant, PTPRZ1-MET fusion–positive astrocytoma or glioblastoma.

Toripalimab NDA Under Review in Hong Kong for Nasopharyngeal Carcinoma

April 25th 2024

A new drug application seeking the approval of toripalimab for the treatment of patients with nasopharyngeal carcinoma is under review in Hong Kong.

Enzalutamide Receives Go Ahead From European Commission in nmHSPC

April 24th 2024

The European Commission has approved enzalutamide as monotherapy and in combination with ADT in BCR nonmetastatic hormone-sensitive prostate cancer.