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 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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Adagrasib Demonstrates Favorable Efficacy, Pharmacokinetic Profile in Advanced KRAS G12C+ NSCLC
March 25th 2021Adagrasib yielded durable responses and broad disease control, in addition to providing extensive predicted coverage throughout the dosing interval, in patients with KRAS G12C–mutant advanced non–small cell lung cancer.
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Pemigatinib Approved in Japan for Unresectable, FGFR+ Biliary Tract Cancer
March 23rd 2021The Japanese Ministry of Health, Labour, and Welfare has approved pemigatinib for the treatment of patients with unresectable biliary tract cancer with a FGFR2 fusion gene, worsening following chemotherapy.
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CA-125 Level Informs Surveillance Strategy for Olaparib/Bevacizumab in Ovarian Cancer
March 19th 2021CA-125 surveillance alone could be used to detect disease progression in patients with advanced ovarian cancer and an abnormal CA-125 level at the beginning of frontline maintenance therapy with olaparib and bevacizumab, according to an analysis from the phase 3 PAOLA-1.
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Daratumumab Plus Rd Prolongs PFS in Frail, Newly Diagnosed, Transplant-Ineligible Myeloma
March 18th 2021The addition of daratumumab to lenalidomide and dexamethasone resulted in improved progression-free survival vs Rd alone in patients with newly diagnosed multiple myeloma who were not eligible for transplant—even in frail patients.
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NICE Recommends Against Olaparib for Metastatic Prostate Cancer
March 8th 2021The United Kingdom’s National Institute for Health and Care Excellence will not recommend olaparib for the treatment of patients with hormone-relapsed, metastatic prostate cancer that harbors BRCA1 or BRCA2 mutations that has progressed on abiraterone acetate or enzalutamide.
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Maintenance Lenalidomide Safe, Should Be Continued in Patients With Myeloma Who Contract COVID-19
March 5th 2021Maintenance treatment with lenalidomide was found to be a safe treatment for patients with multiple myeloma who are diagnosed with COVID-19, supporting use of the immunomodulatory drug in this patient population.
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Melphalan Triplets Elicit Responses, Are Safe in Relapsed/Refractory Multiple Myeloma
March 5th 2021The triplet regimen of melphalan flufenamide with dexamethasone and either daratumumab or bortezomib demonstrated encouraging clinical activity and was well tolerated in patients with heavily pretreated relapsed/refractory multiple myeloma.
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Ixazomib Triplets Show Efficacy in Transplant-Ineligible Newly Diagnosed Multiple Myeloma
March 4th 2021Ixazomib-based triplet regimens as induction therapy elicited higher rates of efficacy compared with ixazomib/dexamethasone alone, followed by single-agent ixazomib maintenance, in patients with transplant-ineligible newly diagnosed multiple myeloma.
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Dostarlimab Gets Positive EU Opinion in Recurrent or Advanced MSI-H Endometrial Cancer
February 26th 2021February 26, 2021 - The European Medicines Agency’s Committee for Medicinal Products for Human Use granted a positive opinion to dostarlimab as a treatment for patients with recurrent or advanced microsatellite instability–high/mismatch repair deficient endometrial cancer who have progressed on or following platinum-based chemotherapy.
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Cabozantinib/Nivolumab Approaches EU Approval for Frontline Advanced RCC
February 26th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the combination of cabozantinib plus nivolumab for use as a frontline treatment in patients with advanced renal cell carcinoma.
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Pamrevlumab May Address Unmet Need for Locally Advanced Pancreatic Cancer
February 17th 2021February 17, 2021 – Pamrevlumab, a first-in-class inhibitor of connective tissue growth factor activity, is being evaluated in combination with gemcitabine and nab-paclitaxel (Abraxane) in a phase 3 trial for patients with unresectable locally advanced pancreatic cancer, a population in need of new options.
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Fedratinib Approved in Europe for Newly Diagnosed and Previously Treated Myelofibrosis
February 9th 2021February 9, 2021 - The European Commission has granted a full marketing authorization for fedratinib for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocytopenia myelofibrosis who have not received JAK inhibitors or who have received ruxolitinib.
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Gilteritinib Receives Conditional Approval in China for FLT3+ AML
February 4th 2021February 4, 2021 - The China National Medical Products Administration has granted a conditional approval to gilteritinib for use in adult patients with relapsed or refractory acute myeloid leukemia with a FLT3 mutation detected by a validated test.
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