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.

Novartis Signs In-Licensing Agreement With BeiGene to Expand Tislelizumab Trials Globally

January 26th 2021

January 26, 2021 - Novartis has signed a strategic collaboration agreement to in-license the PD-1 inhibitor tislelizumab from BeiGene, Ltd, in various markets outside of China.

Frontline Pembrolizumab Approved in Europe for Metastatic MSI-H/dMMR CRC

January 26th 2021

January 26, 2021 - The European Commission has approved single-agent pembrolizumab for use in the frontline treatment of patients with metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer.

Toripalimab Granted FDA Fast Track Status for Mucosal Melanoma

January 25th 2021

January 25, 2021 - The FDA has granted toripalimab a fast track designation for use in the frontline treatment of patients with mucosal melanoma.

Acalabrutinib Approved in Japan for Relapsed/Refractory CLL

January 25th 2021

January 25, 2021 - The Japanese Ministry of Health, Labour and Welfare approved the BTK inhibitor acalabrutinib for use in adult patients with relapsed/refractory chronic lymphocytic leukemia, including small lymphocytic lymphoma

Avelumab Approved in Europe for Frontline Maintenance in Metastatic Urothelial Carcinoma

January 25th 2021

January 25, 2021 - The European Commission has approved avelumab for use as a frontline maintenance option in the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who did not progress after having received platinum-based chemotherapy.

Axicabtagene Ciloleucel Approved in Japan for Relapsed/Refractory LBCL

January 22nd 2021

January 22, 2021 — The Japan Ministry of Health, Labour and Welfare has approved the CAR T-cell therapy axicabtagene ciloleucel for use in the treatment of adult patients with certain relapsed/refractory large B-cell lymphomas.

Trastuzumab Deruxtecan Approved in Europe for HER2+ Metastatic Breast Cancer

January 20th 2021

January 20, 2021 - The antibody-drug conjugate trastuzumab deruxtecan has been granted conditional approval in the European Union for use as a single agent in the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received 2 or more HER2-based regimens.

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.