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.
EU Panel Recommends Nivolumab/Ipilimumab in Frontline Unresectable Malignant Pleural Mesothelioma
April 23rd 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the combination of nivolumab and ipilimumab as a frontline treatment for adult patients with unresectable malignant pleural mesothelioma.
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Oral Azacitidine Recommended for EU Approval in AML
April 23rd 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion for the approval of oral azacitidine as a maintenance treatment for adult patients with acute myeloid leukemia who had a complete remission or CR with incomplete blood count recovery after induction therapy with or without consolidation treatment, and who are ineligible for or choose to not undergo hematopoietic stem cell transplant
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Venetoclax-Based Regimens Get European Nod for Newly Diagnosed, Chemo-Ineligible AML
April 23rd 2021The European Medicines Agency Committee for Medicinal Products for Human Use has recommended to approve venetoclax for use in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy.
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Dostarlimab Approved in Europe for Advanced dMMR Endometrial Cancer
April 23rd 2021The European Commission has granted conditional marketing authorization to dostarlimab for the treatment of patients with microsatellite instability–high/mismatch repair deficient recurrent or advanced endometrial cancer who have progressed on or following prior therapy with a platinum-containing regimen.
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Toripalimab/Chemo Combo Improves Survival in Frontline Esophageal Squamous Cell Carcinoma
April 22nd 2021The frontline combination of toripalimab and cisplatin/paclitaxel reached its prespecified primary end points of progression-free and overall survival in patients with advanced esophageal squamous cell carcinoma in the phase 3 JUPITER-06 trial.
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NICE Recommends Trastuzumab Deruxtecan in Advanced HER2+ Breast Cancer
April 20th 2021The National Institute for Health and Care Excellence has published draft guidance that recommends fam-trastuzumab deruxtecan-nxki for the treatment of patients with unresectable or metastatic HER2-positive breast cancer following 2 or more anti-HER2 therapies.
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Tocilizumab May Have Activity Against COVID-19–Associated Cytokine Storm in Myeloma
April 20th 2021Tocilizumab may represent a potential treatment option with double action against cytokine storm due to COVID-19 in a subset of patients with active multiple myeloma and severe infection with the virus.
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Subcutaneous Daratumumab Plus VCd Approved in Canada for Newly Diagnosed Light Chain Amyloidosis
April 19th 2021Health Canada has approved daratumumab injection, a subcutaneous formulation of daratumumab, for use in combination with bortezomib, cyclophosphamide, and dexamethasone in the treatment of patients with newly diagnosed light chain amyloidosis.
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Isatuximab Plus Carfilzomib/Dexamethasone Approved in Europe for Relapsed Myeloma
April 19th 2021The European Commission has approved isatuximab for use in combination with carfilzomib and dexamethasone in the treatment of patients with relapsed multiple myeloma who have received at least 1 previous therapy.
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Adjuvant Osimertinib Approved in China for Early-Stage EGFR+ NSCLC
April 14th 2021The China National Medical Products Administration has approved osimertinib for use as an adjuvant treatment in patients with early-stage non–small cell lung cancer with EGFR exon 19 deletions or exon 21 mutations, following tumor resection with curative intent, with or without adjuvant chemotherapy as recommended by the patient’s physician.
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Duvelisib Granted Positive EU Opinion for Relapsed/Refractory CLL and Refractory Follicular Lymphoma
April 1st 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of single-agent duvelisib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia following at least 2 prior therapies, and follicular lymphoma that is refractory to at least 2 prior systemic treatments.
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Approval Sought for Plinabulin Plus G-CSF in United States and China for Prevention of CIN
April 1st 2021A new drug application has been submitted to the FDA and the China National Medical Products Administration for the use of plinabulin plus granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.
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Gilteritinib Succeeds in Chinese Confirmatory Trial for FLT3-Mutated AML
March 30th 2021Gilteritinib was found to result in a significant improvement in overall survival when used in patients with FLT3-mutated, relapsed/refractory acute myeloid leukemia, meeting the primary end point of the confirmatory phase 3 COMMODORE trial in China.
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Enzalutamide Granted Positive EU Opinion for Metastatic Hormone-Sensitive Prostate Cancer
March 30th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion to recommend an additional indication of enzalutamide for the treatment of adult patients with metastatic hormone-sensitive prostate cancer.
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Selinexor/Dexamethasone Approved in Europe for Relapsed/Refractory Multiple Myeloma
March 29th 2021The European Commission has granted conditional marketing authorization for selinexor for use in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have previously received at least 4 therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody, and have experienced progressive disease on their last therapy.
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Liso-Cel Approved in Japan for Relapsed/Refractory Large B-Cell Lymphoma
March 29th 2021Japan’s Ministry of Health, Labour and Welfare has approved lisocabtagene maraleucel, a CAR T-cell therapy designed to target CD19, for the treatment of patients with relapsed or refractory large B-cell lymphoma, as well as relapsed/refractory follicular lymphoma.
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Adjuvant Nivolumab Takes Step Toward EU Approval in Muscle-Invasive Urothelial Carcinoma
March 29th 2021The European Medicines Agency has validated its type II variation application for nivolumab as an adjuvant treatment for patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.
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Frontline Osimertinib Showcases Real-World Safety, Efficacy in EGFR+ Advanced NSCLC
March 27th 2021Osimertinib (Tagrisso) showcased encouraging efficacy and acceptable safety in patients with EGFR-positive, advanced non–small cell lung cancer. according to real-world findings from an observational, multicenter study.
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Prior Immunotherapy or Osimertinib Negatively Impacts Outcomes With Subsequent Atezolizumab in NSCLC
March 26th 2021Previous exposure to immune checkpoint inhibitors or osimertinib has been linked with poor outcomes in patients with non–small cell lung cancer who were receiving a subsequent atezolizumab-containing regimen.
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EU Panel Recommends Atezolizumab for Frontline PD-L1–High Metastatic NSCLC
March 26th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of atezolizumab for use as a frontline treatment in adult patients with metastatic non–small cell lung cancer whose tumors have a high PD-L1 expression and no EGFR or ALK aberrations.
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Sacituzumab Govitecan Application for Metastatic TNBC Fast-Tracked in Europe
March 26th 2021The European Medicines Agency has validated a Marketing Authorization application for sacituzumab govitecan-hziy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who had previously received at least 2 therapies, including at least 1 therapy for locally advanced or metastatic disease.
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EMA Accepts Application for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer
March 26th 2021The European Medicines Agency has accepted a marketing authorization application for enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant or adjuvant, locally advanced or metastatic setting.
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