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.

Polatuzumab Vedotin Plus R-CHP Approved in Europe for Previously Untreated DLBCL

May 26th 2022

The European Commission has approved the combination of polatuzumab vedotin and rituximab and cyclophosphamide, doxorubicin, and prednisone for use in adult patients with previously untreated diffuse large B-cell lymphoma.

Pembrolizumab Moves Toward EU Approval for Resected Stage IIB/IIC Melanoma

May 20th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab for use as adjuvant therapy in adult and adolescent patients aged 12 years and older with stage IIB or IIC melanoma following complete resection.

European Approval Sought for Adagrasib in Previously Treated KRAS G12C–Mutated NSCLC

May 20th 2022

A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of adagrasib for therapeutic use in previously treated patients with non–small cell lung cancer harboring a KRAS G12C mutation.

Selinexor Combo Approaches EU Approval for Refractory Multiple Myeloma

May 20th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of selinexor in combination with bortezomib and low-dose dexamethasone for use in adult patients with multiple myeloma who have previously received 1 to 3 prior lines of treatment.

Tisagenlecleucel Approved in Europe for Relapsed/Refractory Follicular Lymphoma

May 17th 2022

The European Commission has approved the CD19-targeting chimeric antigen receptor T-cell agent tisagenlecleucel for the treatment of adults with relapsed/refractory follicular lymphoma following at least 2 lines of systemic therapy.

Cabozantinib Approved in Europe for Second-Line Radioactive Iodine–Refractory Differentiated Thyroid Cancer

May 3rd 2022

The European Commission has approved the use of cabozantinib for use as a single agent in adult patients with locally advanced or metastatic differentiated thyroid carcinoma who are refractory or not eligible to receive radioactive iodine and who have progressed during or following previous systemic treatment.

Neoadjuvant Pembrolizumab/Chemo Followed by Adjuvant Pembrolizumab Approaches EU Approval for High-Risk, Early-Stage TNBC

April 26th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab alone after surgery for adult patients with locally advanced or early-stage triple-negative breast cancer who are at a high risk for recurrence.

Mosunetuzumab Approaches EU Approval for Relapsed or Refractory Follicular Lymphoma

April 25th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval under conditional marketing authorization for mosunetuzumab for use in adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 therapies.

EU Panel Recommends Capmatinib for METex14-Altered Advanced NSCLC

April 23rd 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorization to capmatinib for use as a single agent in select adult patients with advanced non–small cell lung cancer harboring a METex14 skipping alteration.

Adjuvant Atezolizumab Approaches EU Approval for High-Risk NSCLC With PD-L1 of ≥50%

April 22nd 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion supporting the approval of adjuvant atezolizumab, after complete resection and platinum-based chemotherapy, in adult patients with non–small cell lung cancer with a high risk of recurrence and whose tumors express PD-L1 of 50% or higher and do not harbor EGFR mutations or ALK alterations.

Tislelizumab Approved in China for Second-Line Esophageal Squamous Cell Carcinoma

April 18th 2022

The China National Medical Products Administration has approved tislelizumab for use in patients with locally advanced or metastatic esophageal squamous cell carcinoma who have disease progression or who are intolerant to frontline standard chemotherapy.

NICE Makes Avelumab Available for Maintenance Treatment of Urothelial Cancer

April 8th 2022

Avelumab is now a treatment option for patients with urothelial cancer in the United Kingdom following a recommendation from the National Institute for Health and Care Excellence issued Thursday, April 7, 2022.1

Relmacabtagene Autoleucel Gets Breakthrough Therapy Designation for MCL in China

April 7th 2022

The China National Medical Products Administration’s Center for Drug Evaluation has granted a breakthrough therapy designation to relmacabtagene autoleucel for use in the treatment of patients with mantle cell lymphoma.

EMA Accepts Marketing Authorization Applications for Tislelizumab in Select ESCC and NSCLC

April 6th 2022

Marketing authorization applications seeking the approval of tislelizumab in patients with advanced or metastatic esophageal squamous cell carcinoma following previous systemic chemotherapy and in select patients with non–small cell lung cancer have been submitted to the European Medicines Agency.

Nivolumab/Ipilimumab Approved in Europe for Frontline PD-L1+ Advanced ESCC

April 5th 2022

The European Commission has approved the dual immunotherapy combination of nivolumab and ipilimumab for use in the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma who had a PD-L1 expression of 1% or higher on tumor cells.

Lisocabtagene Maraleucel Approved in Europe for Select Relapsed/Refractory LBCL

April 5th 2022

The European Commission has granted marketing authorization to the CD19-directed CAR T-cell therapy lisocabtagene maraleucel for use in adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B following 2 or more lines of systemic treatment.

Nivolumab/Chemo Gets European Approval for Frontline PD-L1+ Advanced Esophageal Squamous Cell Carcinoma

April 5th 2022

The European Commission has approved nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy for the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with a PD-L1 expression of 1% or higher on tumor cells.

Adjuvant Nivolumab Approved in Europe for Select High-Risk Muscle-Invasive Urothelial Carcinoma

April 5th 2022

The European Commission has approved nivolumab for use in the adjuvant treatment of adult patients with muscle-invasive urothelial carcinoma and a PD-L1 expression of 1% or higher on tumor cells, who are at a high risk of recurrence following radical resection.

European Approval Sought for Neoadjuvant Nivolumab/Chemo in Resectable NSCLC

March 29th 2022

The European Medicines Agency has validated its type II variation application for nivolumab in combination with chemotherapy for use in the neoadjuvant treatment of patients with unresectable stage IB to IIIA non–small cell lung cancer.

Pembrolizumab Plus Chemo With or Without Bevacizumab Approaches EU Approval for Select Cervical Cancer

March 28th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab for use in combination with chemotherapy with or without bevacizumab in patients with persistent, recurrent, or metastatic cervical cancer who have a PD-L1 combined positive score of 1 or higher.