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.

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.

Frontline Pembrolizumab Granted Positive EU Opinion in Metastatic MSI-H, dMMR CRC

December 11th 2020

December 11, 2020 - The European Medicine Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for pembrolizumab monotherapy for the frontline treatment of adult patients with metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer.

Ipatasertib/Paclitaxel Fails to Improve PFS in PIK3CA/AKT1/PTEN-Altered TNBC

December 10th 2020

December 10, 2020 — The combination of ipatasertib and paclitaxel failed to show a significant improvement in progression-free survival vs placebo plus paclitaxel in patients with PIK3CA/AKT1/PTEN-altered locally advanced, unresectable or metastatic triple-negative breast cancer.

Ki-67 Can Be Used to Select Abemaciclib for Patients With High-Risk Early Breast Cancer

December 10th 2020

December 10, 2020 - Treatment with abemaciclib in combination with endocrine therapy significantly reduced the risk of invasive disease recurrence or death in patients with hormone receptor–positive, HER2-negative, node-positive, early breast cancer who had high Ki-67 tumors, suggesting that this feature can be used in conjunction with high-risk features to select patients for abemaciclib in the adjuvant setting.

Dr. Zeiser on Results of the REACH3 Trial in Chronic GVHD

December 8th 2020

Robert Zeiser, MD, discusses results of the REACH3 trial in chronic graft-versus-host disease.

Dr. Buske on the Results of the iNNOVATE Trial in Waldenström Macroglobulinemia

December 7th 2020

Christian Buske, MD, discusses the results of the iNNOVATE trial in Waldenström macroglobulinemia.

Oxidative Stress, Antioxidant Status Remain High in Nigerian Patients With Prostate Cancer

December 4th 2020

Nigerian patients with prostate cancer are noted as having higher levels of total plasma peroxide, malondialdehyde, and nitric oxide, as well as lower levels of total antioxidant capacity, even while undergoing androgen-deprivation therapy compared with Nigerian men who don't have prostate cancer.

Pancreatic Cancer Trial Platform Poised to Lead to Quicker, More Efficient Research

November 30th 2020

Vincent J. Picozzi Jr, MD, spotlights the launch of PanCAN’s Precision Promise clinical trial platform, and how it is expected to impact clinical practice.

Cabozantinib Approved in Japan for Advanced Hepatocellular Carcinoma

November 30th 2020

The Japanese Ministry of Health, Labor, and Welfare has approved cabozantinib for the treatment of patients with unresectable hepatocellular carcinoma that has progressed on prior systemic therapy.

Denosumab Approved in China for Prevention of Skeletal-Related Events in Bone Metastases From Solid Tumors, Myeloma

November 23rd 2020

November 23, 2020 - The China National Medical Products Administration has approved denosumab for the prevention of skeletal-related events in patients with bone metastases from solid tumors and in those with multiple myeloma.

FDA, EMA Approval Sought for Subcutaneous Daratumumab Plus Pomalidomide/Dexamethasone in Relapsed/Refractory Myeloma

November 12th 2020

Regulatory applications have been submitted to the FDA and the European Medicines Agency for subcutaneous daratumumab for use in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least 1 previous therapy.

Enzalutamide Approved in China for Nonmetastatic Castration-Resistant Prostate Cancer

November 11th 2020

November 10, 2020 - The China National Medical Products Administration has approved enzalutamide for the treatment of adult patients with nonmetastatic castration-resistant prostate cancer who are at a higher risk of metastasis.

Acalabrutinib Approved in Europe for Chronic Lymphocytic Leukemia

November 10th 2020

November 10, 2020 - The European Union approved the next-generation BTK inhibitor acalabrutinib for use in adult patients with chronic lymphocytic leukemia.

Nivolumab/Ipilimumab Plus Chemo Approved in Europe for Frontline Metastatic NSCLC

November 6th 2020

The European Commission has approved the combination of nivolumab plus ipilimumab with 2 cycles of platinum-based chemotherapy for the up-front treatment of adult patients with metastatic non–small cell lung cancer without a sensitizing EGFR mutation or an ALK translocation.