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.

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.

EU Panel Recommends Frontline Nivolumab/Chemo for PD-L1+ Unresectable Advanced, Recurrent or Metastatic ESCC

February 25th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to the use of nivolumab in combination with chemotherapy in the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma with a PD-L1 expression of 1% or higher.

Adjuvant Nivolumab Approaches EU Approval for Select High-Risk Muscle-Invasive Urothelial Carcinoma

February 25th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab for use as an adjuvant treatment in adult patients with muscle-invasive urothelial carcinoma with a PD-L1 expression of at least 1% on tumor cells, who are at a high risk of recurrence following radical resection.

Zanubrutinib Applications for CLL and MZL Accepted for Review in Europe

February 23rd 2022

The European Medicines Agency has accepted for review 2 new indication applications for zanubrutinib as a therapeutic option for patients with chronic lymphocytic leukemia and for those with marginal zone lymphoma.

Tepotinib Approved in Europe for METex14-Altered Advanced NSCLC

February 21st 2022

The European Commission has approved tepotinib for use as a single agent in adult patients with advanced non–small cell lung cancer harboring METex14 skipping alterations who require systemic therapy after prior treatment with immunotherapy and/or platinum-based chemotherapy.

Frontline Niraparib Plus Abiraterone Improves rPFS in HRR Gene–Altered mCRPC

February 17th 2022

The combination of niraparib and abiraterone acetate and prednisone led to a significant improvement in radiographic progression-free survival vs placebo plus abiraterone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations.

Pelareorep/Atezolizumab Plus Chemo Shows Early Safety in Frontline Metastatic Pancreatic Cancer

February 3rd 2022

The 3-patient safety run-in for the pancreatic cancer cohort of the ongoing phase 1/2 GOBLET study did not reveal any safety concerns with the novel combination of pelareorep and atezolizumab.

Zanubrutinib sNDA for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Accepted in China

February 1st 2022

The China National Medical Products Administration has accepted a supplemental new drug application for zanubrutinib as a treatment option for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.