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.

VCN-01 Earns Orphan Medicinal Product Designation in Europe for Retinoblastoma

October 16th 2024

The European Commission has granted orphan medicinal product designation to VCN-01 for the treatment of patients with retinoblastoma.

Toripalimab Wins Approval in India and Hong Kong for Recurrent/Metastatic Nasopharyngeal Carcinoma

October 15th 2024

Toripalimab has been approved in India and China’s Hong Kong Special Administrative Region for recurrent or metastatic nasopharyngeal carcinoma.

Sunvozertinib Receives Breakthrough Therapy Designation for Treatment-Naive EGFR Exon 20+ NSCLC in China

October 14th 2024

China’s CDE has granted breakthrough therapy designation to first-line sunvozertinib for EGFR exon 20 insertion mutation–positive NSCLC.

NMPA Grants Marketing Approval to NGS-Based Companion Diagnostic for Sunvozertinib in EGFR Exon 20+ NSCLC

October 11th 2024

A next generation sequencing–based companion diagnostic has received marketing approval in China for sunvozertinib in EGFR exon 20–positive NSCLC.

EU Approval Sought for D-VRd in Newly Diagnosed Myeloma

October 10th 2024

A Type II variation application has been submitted to the EMA for subcutaneous daratumumab plus VRd in newly diagnosed multiple myeloma.

LBL-024 Receives Breakthrough Therapy Designation in China for Extrapulmonary Neuroendocrine Carcinoma

October 9th 2024

LBL-024 received breakthrough therapy designation in China for pretreated advanced extrapulmonary neuroendocrine carcinoma.

Health Canada Expands Indication for Illuccix Diagnostic Kit for PSMA-Targeted Radioligand Therapy in mCRPC

October 7th 2024

Illuccix has been approved in Canada for the selection of patients with mCRPC eligible for treatment with PSMA1-targeted radionuclide therapy.

Trastuzumab/Pertuzumab May Be an Effective Chemo-Free Regimen in HR+/HER2+ Breast Cancer

October 2nd 2024

Dual HER2 blockade with trastuzumab plus pertuzumab may serve as an effective option for hormone receptor–positive, HER2-positive metastatic breast cancer.

Toripalimab Plus Chemo Wins European Approval for Nasopharyngeal Carcinoma and Esophageal Squamous Cell Carcinoma

September 25th 2024

The European Commission has approved toripalimab in indications for nasopharyngeal carcinoma and esophageal squamous cell carcinoma.

Frontline Enfortumab Vedotin Plus Pembrolizumab Receives Approval in Japan for Unresectable Urothelial Carcinoma

September 24th 2024

Enfortumab vedotin plus pembrolizumab has been approved in Japan for first-line radically unresectable urothelial carcinoma.

Japan’s MHLW Approves Fruquintinib in Pretreated mCRC After Chemotherapy

September 24th 2024

Japan’s Ministry of Health, Labour, and Welfare approved fruquintinib in metastatic colorectal cancer following progression with chemotherapy.

First-Line Serplulimab Receives Positive CHMP Opinion for ES-SCLC

September 23rd 2024

The CHMP has recommended the European approval of serplulimab for the first-line treatment of extensive-stage small cell lung cancer.

Subcutaneous Daratumumab Quadruplet Approaches EU Approval for Newly Diagnosed Myeloma

September 20th 2024

The EMA's CHMP has recommended the approval of subcutaneous daratumumab plus VRd in patients with newly diagnosed, transplant-eligible multiple myeloma.

Pembrolizumab-Based Regimens Earn Positive CHMP Opinion in Endometrial and Cervical Cancers

September 20th 2024

The CHMP has issued positive opinions for 2 pembrolizumab-based regimens for select patients with endometrial and cervical cancers.

CHMP Recommends Mirvetuximab Soravtansine for FRα+ Ovarian Cancer

September 20th 2024

The EMA’s CHMP has recommended the marketing authorization of mirvetuximab soravtansine for FRα-positive, platinum-resistant epithelial ovarian cancer.

Tislelizumab Receives Israeli Approval in Unresectable or Metastatic ESCC

September 17th 2024

Tislelizumab has been approved by the Israeli Ministry of Health for pretreated patients with unresectable or metastatic esophageal squamous cell carcinoma.

Adjuvant Ribociclib Sustains DFS, DDFS Benefit in HR+/HER2– Breast Cancer

September 16th 2024

Adding ribociclib to a NSAI in the adjuvant setting prolonged invasive and distant disease-free survival in HR-positive, HER2-negative early breast cancer.

Long-Term KEYNOTE-006 Data Support Pembrolizumab as SOC in Advanced Melanoma

September 15th 2024

Pembrolizumab continued to demonstrate improved survival vs ipilimumab in unresectable stage III or IV melanoma.

Ramucirumab Plus TAS-102 Fails to Improve OS in Heavily Pretreated mCRC

September 15th 2024

Ramucirumab plus trifluridine/tipiracil failed to improve overall survival vs TAS-102 alone in patients with heavily pretreated metastatic colorectal cancer.

Neoadjuvant Pembrolizumab/Chemo, Adjuvant Pembrolizumab Boosts OS in Early TNBC

September 15th 2024

Neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab, improved overall survival in triple-negative breast cancer.