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.

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.

Lisocabtagene Maraleucel sNDA for Second-Line Relapsed/Refractory LBCL Accepted for Review in Japan

March 26th 2022

The Ministry of Health, Labour, and Welfare has accepted a supplemental new drug application for lisocabtagene maraleucel for the second-line treatment of patients with relapsed or refractory large B-cell lymphoma.

Avapritinib Approved in Europe for Advanced Systemic Mastocytosis

March 25th 2022

The European Commission has expanded the current indication for avapritinib to include use as a single agent in adult patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, or mast cell leukemia, following at least 1 systemic treatment.

CHMP Moves to Recommend Pembrolizumab for MSI-H/dMMR Cancers

March 25th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended pembrolizumab for the treatment of adult patients with a variety of microsatellite instability-high or mismatch repair deficient tumors.

Polatuzumab Vedotin Plus R-CHP Recommended for EU Approval for Previously Untreated DLBCL

March 25th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of the approval of polatuzumab vedotin for use in combination with rituximab plus cyclophosphamide, doxorubicin, and prednisone in patients with previously untreated diffuse large B-cell lymphoma.

EU Panel Recommends Ruxolitinib for Acute or Chronic Graft-Vs-Host Disease

March 25th 2022

The European Medicines Agency’s Committee for Medical Products for Human Use has recommended the approval of ruxolitinib for the treatment of patients with acute or chronic graft-vs-host disease who are aged 12 years or older and who have inadequate response to corticosteroids or other systemic therapies.

Tisagenlecleucel Approaches EU Approval for Relapsed/Refractory Follicular Lymphoma

March 25th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of tisagenlecleucel for use in adult patients with relapsed/refractory follicular lymphoma following 2 lines of systemic treatment.

Experts Survey Treatment Variations for Resectable NSCLC in Asian Populations

March 25th 2022

A panel of lung cancer experts from China, South Korea, and Japan share their insights on how they care for their patients with resectable EGFR-positive non–small cell lung cancer.

FDA Issues Complete Response Letter to Sintilimab/Chemo for Frontline Nonsquamous NSCLC

March 24th 2022

The FDA has issued a complete response letter to the biologics license application seeking the approval of sintilimab injection in combination with pemetrexed and platinum chemotherapy in the frontline treatment of patients with nonsquamous non–small cell lung cancer.

Guardant360 CDx Approved in Japan for Utilization in Advanced Solid Tumors

March 16th 2022

The Ministry of Health, Labour, and Welfare has approved Guardant360 CDx to perform comprehensive genomic profiling in patients with advanced solid cancers.

European Approval Sought for Ivosidenib in IDH1-Mutated AML and Cholangiocarcinoma

March 10th 2022

A marketing authorization application has been submitted to the European Medicines Agency for 2 indications of ivosidenib: in combination with azacitidine in the frontline treatment of patients with IDH1-mutated acute myeloid leukemia who are not candidates for intensive chemotherapy and in previously treated patients with locally advanced or metastatic IDH1-mutated cholangiocarcinoma.

NICE Rejects Pembrolizumab Plus Chemotherapy for Select Metastatic TNBC

March 9th 2022

The United Kingdom’s National Institute for Health and Clinical Excellence has issued draft guidance recommending against pembrolizumab plus chemotherapy as a treatment for patients with metastatic triple-negative breast cancer whose tumors express PD-L1 with a combined positive score of 10 or more and who have not received chemotherapy for metastatic disease.

EU Panel Confirms Recommendation for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer

February 28th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has confirmed its recommendation to approve the use of enfortumab vedotin in adult patients with locally advanced or metastatic urothelial cancer who have received prior platinum-based chemotherapy and a PD-1/PD-L1 inhibitor.

Nivolumab/Ipilimumab Nears EU Approval for Frontline PD-L1+ Unresectable Advanced, Recurrent or Metastatic ESCC

February 25th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab and ipilimumab for use in 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.