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.

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.

European Approval Sought for Teclistamab in Relapsed/Refractory Multiple Myeloma

February 1st 2022

A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma.

EU Panel Recommends Avapritinib for Advanced Systemic Mastocytosis

January 31st 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended to expand the current indication for avapritinib to include single-agent use in patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, or mast cell leukemia.

Liso-cel Approaches EU Approval for Relapsed/Refractory DLBCL, PMBCL, and Follicular Lymphoma Grade 3B

January 28th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of lisocabtagene maraleucel for the treatment of 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 therapy.

Lorlatinib Approved in Europe for ALK+ Advanced NSCLC

January 28th 2022

The European Commission has granted a marketing authorization for lorlatinib for use as a single agent in the treatment of adult patients with ALK-positive advanced non–small cell lung cancer who did not receive a prior ALK inhibitor.

Zanubrutinib sNDA for Waldenström Macroglobulinemia Accepted in China

January 21st 2022

The China National Medical Products Administration has accepted a supplemental new drug application for zanubrutinib as a treatment for adult patients with Waldenström macroglobulinemia.

Key Markers in Gut Microbiome May Predict Skin-Related AEs With Nivolumab in Advanced Gastric Cancer

January 20th 2022

The presence of Arthrobacter and fatty acid metabolism pathways in gut microbiomes may be linked to an increased risk of skin-related adverse events in patients with advanced gastric cancer who are receiving single-agent nivolumab.

Idecabtagene Vicleucel Approved in Japan for Relapsed/Refractory Multiple Myeloma

January 20th 2022

The Japanese Ministry of Health, Labour, and Welfare has approved idecabtagene vicleucel for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least 3 therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have progressed on their last therapy or relapsed following their last therapy.

Nivolumab Misses Mark in Japanese Patients With Platinum-Resistant Ovarian Cancer

January 18th 2022

Nivolumab did not significantly improve overall survival compared with chemotherapy in Japanese patients with platinum-resistant ovarian cancer.

NHS Scotland Accepts Trastuzumab Deruxtecan for Use in HER2+ Metastatic Breast Cancer

January 17th 2022

The Scottish Medicines Consortium has accepted fam-trastuzumab deruxtecan-nxki as a treatment option for adult patients with HER2-positive unresectable or metastatic breast cancer who have previously received 2 or more anti–HER2-based therapies.

Sotorasib Approved in Europe for KRAS G12C–Mutated Advanced NSCLC

January 10th 2022

The European Commission has granted conditional marketing authorization to sotorasib for the treatment of adult patients with KRAS G12C mutant advanced non–small cell lung cancer.

Japanese Approval Sought for Valemetostat in Relapsed/Refractory Adult T-Cell Leukemia/Lymphoma

January 3rd 2022

A new drug application seeking the approval of valemetostat tosylate for use in the treatment of patients with relapsed/refractory adult T-cell leukemia/lymphoma has been submitted to the Japanese Ministry of Health, Labour, and Welfare.

Pembrolizumab/Lenvatinib Approved in Japan for Endometrial Cancer Following Progression on Chemo

January 3rd 2022

The Japanese Ministry of Health, Labour, and Welfare has approved the combination of pembrolizumab plus lenvatinib for use in patients with unresectable, advanced, or recurrent endometrial carcinoma that has progressed on chemotherapy.

Selinexor Approved in China for Relapsed or Refractory Multiple Myeloma

December 22nd 2021

The China National Medical Products Administration has granted a conditional marketing approval to selinexor for use in combination with dexamethasone in patients with relapsed or refractory multiple myeloma who have previously received treatment and whose disease is refractory to at least a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Japanese Approval Sought for Trastuzumab Deruxtecan in HER2+ Metastatic Breast Cancer

December 21st 2021

A supplemental new drug application has been submitted to Japan’s Ministry of Health, Labour, and Welfare or the use of fam-trastuzumab deruxtecan-nxki as a treatment in select patients with HER2-positive unresectable or recurrent breast cancer.