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.

Fixed-Dose Durvalumab Approved in Europe for Unresectable NSCLC

January 15th 2021

January 15, 2021 - Durvalumab has been approved in the European Union and the United Kingdom for a fixed-dose option of 1,500 mg every 4 weeks for use in patients with locally advanced, unresectable non–small cell lung cancer whose tumors have a PD-L1 expression of at least 1% and who have not experienced disease progression after platinum-based chemoradiation treatment.

Sintilimab Injection Second-Line Squamous NSCLC Application Accepted in China

January 14th 2021

January 14, 2020 — The National Medical Products Administration of China has accepted a supplemental new drug application for sintilimab injection for use in the second-line treatment of patients with squamous non–small cell lung cancer.

Frontline Tislelizumab/Chemo Approved in China for Advanced Squamous NSCLC

January 14th 2021

January 14, 2020 - The China National Medical Products Administration has approved tislelizumab for use in combination with 2 chemotherapy regimens in the frontline treatment of patients with advanced squamous non–small cell lung cancer.

CLL Paradigm Prepares to Expand With Novel Therapies as Chemo Is Phased Out

January 13th 2021

James Gerson, MD, discusses how he navigates treatment selection for patients with CLL and exciting developments in the pipeline.

Ibrutinib/Rituximab Approved in Canada for CLL

January 13th 2021

January 13, 2021 - Health Canada has approved the combination of ibrutinib and rituximab for use in patients with treatment-naïve chronic lymphocytic leukemia.

NICE Rejects Nivolumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

January 8th 2021

January 8th, 2021 - The United Kingdom’s National Institute for Health and Care Excellence has issued guidelines recommending against nivolumab for use in patients with recurrent or metastatic head and neck squamous cell carcinoma who experienced disease progression during or after platinum-based chemotherapy.

RAF/MEK Inhibitor VS-6766 Plus Defactinib Under Exploration in Recurrent Low-Grade Serous Ovarian Cancer

January 6th 2021

January 6, 2021 — The oral small molecule inhibitor VS-6766, developed by Verastem Oncology, is now under investigation alone and in combination with the FAK inhibitor defactinib in a recently initiated, registration-directed, phase 2 trial in patients with recurrent low-grade serous ovarian cancer.

Japanese Approval Sought for Oncolytic Virus Teserpaturev for Malignant Glioma

January 5th 2021

January 5, 2020 - A new drug application has been submitted to Japan’s Ministry of Health, Labour, and Welfare for the oncolytic virus teserpaturev for use in the treatment of patients with malignant glioma.

Approval for Amivantamab Sought in Europe for Metastatic EGFR Exon 20+ NSCLC

January 4th 2021

January 4th, 2021 - A marketing authorization application has been submitted to the European Medicines Agency for the approval of amivantamab as a treatment for patients with metastatic non–small cell lung cancer that harbors EGFR exon 20 insertion mutations who have experienced disease progression following platinum-based chemotherapy.

EU Approval Sought for Sotorasib in KRAS G12C–Mutated Advanced or Metastatic NSCLC

January 4th 2021

January 4, 2021 - A marketing authorization application has been submitted to the European Medicines Agency for the use of sotorasib in patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer.

Surufatinib Approved in China for Non-Pancreatic Neuroendocrine Tumors

December 30th 2020

December 30, 2020 - The China National Medical Products Administration has approved surufatinib for the treatment of patients with non-pancreatic neuroendocrine tumors.

Fixed-Dose Pertuzumab/Trastuzumab Combo Approved in Europe for HER2+ Breast Cancer

December 23rd 2020

December 23, 2020 - The European Commission has approved the fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase, to be administered via a subcutaneous injection in the treatment of patients with early and metastatic HER2-positive breast cancer.

Dr. Al-Sawaf on the Limitations of Continuous Therapy Administration in CLL

December 22nd 2020

Othman Al-Sawaf, MD, discusses the limitations of continuous therapy administration in chronic lymphocytic leukemia.

KTE-X19 Approved in Europe for Relapsed/Refractory MCL

December 17th 2020

December 17, 2020 — The European Commission has granted a conditional marketing authorization to the CD19-targeted CAR T-cell therapy KTE-X19 for use in adult patients with relapsed or refractory mantle cell lymphoma who had previously received 2 or more lines of systemic therapy including a BTK inhibitor.

Dr. Price on the Rationale for Sotorasib in Advanced Gastrointestinal Cancers

December 16th 2020

Timothy Price, MBBS, DHthSc, FRACP, discusses the rationale to evaluate sotorasib in gastrointestinal cancers.

Fixed-Dose Durvalumab Nears EU Approval for Unresectable NSCLC

December 15th 2020

December 15, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for an additional dosing option of durvalumab, a fixed dose of 1500 mg every 4 weeks, in the approved indication of locally advanced, unresectable non–small cell lung cancer in adults whose tumors have a PD-L1 expression of at least 1% and who did not have progressive disease after platinum-based chemoradiation treatment.

ctDNA Positivity Correlates With Improved Survival With Atezolizumab in High-Risk Muscle-Invasive Bladder Cancer

December 12th 2020

Circulating tumor DNA positivity identified patients with high-risk muscle-invasive urothelial cancer who were likely to derive improvements in disease-free survival and overall survival from adjuvant atezolizumab vs observation.

Dr. Harbeck on Ki-67 as a Biomarker for Identifying High-Risk Early Breast Cancer

December 12th 2020

Nadia Harbeck, MD, PhD, discusses Ki-67 as a biomarker for identifying patients with high-risk early breast cancer who received treatment on the monarchE trial.

Positive EU Opinion Granted to Avelumab for Frontline Maintenance in Locally Advanced or Metastatic Urothelial Carcinoma

December 11th 2020

December 11, 2020 - The European Medicine Agency’ s Committee for Medicinal Products for Human Use has granted a positive opinion to avelumab as a single agent, frontline maintenance option for adult patients with locally advanced or metastatic urothelial carcinoma who are free of disease progression after platinum-based chemotherapy.

EU Panel Recommends Tucatinib for Locally Advanced or Metastatic HER2+ Breast Cancer

December 11th 2020

December 11, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to tucatinib in combination with trastuzumab and capecitabine for use in adult patients with HER2-positive, locally advanced or metastatic breast cancer who had received at least 2 previous anti-HER2 therapies.