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.

Approval Sought for Plinabulin Plus G-CSF in United States and China for Prevention of CIN

April 1st 2021

A new drug application has been submitted to the FDA and the China National Medical Products Administration for the use of plinabulin plus granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.

Cabozantinib/Nivolumab Combo Approved in Europe for Advanced RCC

March 31st 2021

The European Commission has approved the combination of cabozantinib plus nivolumab for use as a frontline treatment in patients with advanced renal cell carcinoma.

Gilteritinib Succeeds in Chinese Confirmatory Trial for FLT3-Mutated AML

March 30th 2021

Gilteritinib was found to result in a significant improvement in overall survival when used in patients with FLT3-mutated, relapsed/refractory acute myeloid leukemia, meeting the primary end point of the confirmatory phase 3 COMMODORE trial in China.

EU Panel Recommends Updated Label for Pembrolizumab in Select Locally Advanced or Metastatic Urothelial Cancer

March 30th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of recommending that the label for pembrolizumab in Europe be updated to include findings from the phase 3 KEYNOTE-361 trial.

Enzalutamide Granted Positive EU Opinion for Metastatic Hormone-Sensitive Prostate Cancer

March 30th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion to recommend an additional indication of enzalutamide for the treatment of adult patients with metastatic hormone-sensitive prostate cancer.

Dr. Au on the Impact of COVID-19 on Cancer Care

March 29th 2021

Lewis Au, MBBS, BMedSci, FRACP, discusses the impact that COVID-19 has had and will continue to have on cancer care.

Selinexor/Dexamethasone Approved in Europe for Relapsed/Refractory Multiple Myeloma

March 29th 2021

The European Commission has granted conditional marketing authorization for selinexor for use in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have previously received at least 4 therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody, and have experienced progressive disease on their last therapy.

Liso-Cel Approved in Japan for Relapsed/Refractory Large B-Cell Lymphoma

March 29th 2021

Japan’s Ministry of Health, Labour and Welfare has approved lisocabtagene maraleucel, a CAR T-cell therapy designed to target CD19, for the treatment of patients with relapsed or refractory large B-cell lymphoma, as well as relapsed/refractory follicular lymphoma.

Adjuvant Nivolumab Takes Step Toward EU Approval in Muscle-Invasive Urothelial Carcinoma

March 29th 2021

The European Medicines Agency has validated its type II variation application for nivolumab as an adjuvant treatment for patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.

Frontline Osimertinib Showcases Real-World Safety, Efficacy in EGFR+ Advanced NSCLC

March 27th 2021

Osimertinib (Tagrisso) showcased encouraging efficacy and acceptable safety in patients with EGFR-positive, advanced non–small cell lung cancer. according to real-world findings from an observational, multicenter study.

Prior Immunotherapy or Osimertinib Negatively Impacts Outcomes With Subsequent Atezolizumab in NSCLC

March 26th 2021

Previous exposure to immune checkpoint inhibitors or osimertinib has been linked with poor outcomes in patients with non–small cell lung cancer who were receiving a subsequent atezolizumab-containing regimen.

EU Panel Recommends Atezolizumab for Frontline PD-L1–High Metastatic NSCLC

March 26th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of atezolizumab for use as a frontline treatment in adult patients with metastatic non–small cell lung cancer whose tumors have a high PD-L1 expression and no EGFR or ALK aberrations.

Sacituzumab Govitecan Application for Metastatic TNBC Fast-Tracked in Europe

March 26th 2021

The European Medicines Agency has validated a Marketing Authorization application for sacituzumab govitecan-hziy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who had previously received at least 2 therapies, including at least 1 therapy for locally advanced or metastatic disease.

EMA Accepts Application for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer

March 26th 2021

The European Medicines Agency has accepted a marketing authorization application for enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant or adjuvant, locally advanced or metastatic setting.

Adagrasib Demonstrates Favorable Efficacy, Pharmacokinetic Profile in Advanced KRAS G12C+ NSCLC

March 25th 2021

Adagrasib yielded durable responses and broad disease control, in addition to providing extensive predicted coverage throughout the dosing interval, in patients with KRAS G12C–mutant advanced non–small cell lung cancer.

Pemigatinib Approved in Japan for Unresectable, FGFR+ Biliary Tract Cancer

March 23rd 2021

The Japanese Ministry of Health, Labour, and Welfare has approved pemigatinib for the treatment of patients with unresectable biliary tract cancer with a FGFR2 fusion gene, worsening following chemotherapy.

CA-125 Level Informs Surveillance Strategy for Olaparib/Bevacizumab in Ovarian Cancer

March 19th 2021

CA-125 surveillance alone could be used to detect disease progression in patients with advanced ovarian cancer and an abnormal CA-125 level at the beginning of frontline maintenance therapy with olaparib and bevacizumab, according to an analysis from the phase 3 PAOLA-1.

Dr. Hurley on Breast Cancer Baseline Characteristics in the Caribbean Vs the United States

March 18th 2021

Judith E. Hurley, MD, discusses the baseline characteristics of patients with breast cancer in the Caribbean vs those in the United States.

Companies Collaborate to Develop Companion Diagnostic for Immunotherapy in HPV-Associated Cervical Dysplasia

March 18th 2021

QIAGEN and INOVIO Pharmaceuticals, Inc. are extending their collaborative efforts with a new agreement to develop liquid biopsy–based companion diagnostic assays for INOVIO agents, according to a news release from INOVIO.

Daratumumab Plus Rd Prolongs PFS in Frail, Newly Diagnosed, Transplant-Ineligible Myeloma

March 18th 2021

The addition of daratumumab to lenalidomide and dexamethasone resulted in improved progression-free survival vs Rd alone in patients with newly diagnosed multiple myeloma who were not eligible for transplant—even in frail patients.