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.
Pembrolizumab/Chemo Approved in Europe for Select Locally Recurrent Unresectable or Metastatic TNBC
October 22nd 2021The European Commission has approved pembrolizumab plus chemotherapy for the frontline treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 expression combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.
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The European Commission has approved nivolumab plus fluoropyrimidine- and platinum-based chemotherapy for the frontline treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors have a PD-L1 combined positive score of 5 or higher.
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Relatlimab/Nivolumab Application for Frontline Advanced Melanoma Validated by EMA
October 1st 2021The European Medicines Agency has validated its marketing authorization application for the fixed-dose combination of relatlimab and nivolumab in the frontline treatment of adult and pediatric patients with advanced melanoma.
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Infigratinib Approved in Canada for FGFR2+ Cholangiocarcinoma
September 29th 2021Health Canada has approved infigratinib for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma harboring a FGFR2 fusion or other rearrangement.
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Taletrectinib Elicits Encouraging Responses in Crizotinib-Pretreated ROS1+ NSCLC
September 28th 2021The investigational next-generation ROS1/NTRK inhibitor taletrectinib was found to elicit encouraging responses with an acceptable toxicity profile in patients with ROS1-positive non–small cell lung cancer, according to preliminary data from the phase 2 TRUST trial.
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Pembrolizumab/Chemo Nears EU Approval for Select TNBC With PD-L1 CPS ≥10
September 17th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion of pembrolizumab plus chemotherapy in the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.
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EU Panel Recommends Pralsetinib for RET Fusion+ Advanced NSCLC
September 17th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pralsetinib for use as a single agent in adult patients with RET fusion–positive advanced non–small cell lung cancer who did not receive prior RET inhibition.
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The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab plus fluoropyrimidine and platinum-containing chemotherapy as frontline treatment for adult patients with HER2-negative advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma with a PD-L1 combined positive score of 5 or higher.
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Melflufen/Dexamethasone Improves PFS in Transplant-Naïve Relapsed/Refractory Multiple Myeloma
September 12th 2021Melphalan flufenamide (melflufen) plus dexamethasone demonstrated an improvement in progression-free survival vs pomalidomide/dexamethasone in patients with transplant-naïve relapsed/refractory multiple myeloma.
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TDM-1/Osimertinib Combo Has Limited Efficacy for Resistant EGFR+ NSCLC
September 8th 2021The combination of ado-trastuzumab emtansine and osimertinib demonstrated minimal antitumor effects on patients with EGFR-mutated non–small cell lung cancer, according to interim data of the phase 2 TRAEMOS trial.
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Pembrolizumab Approved in China for Frontline Advanced Esophageal or GEJ Cancer
September 7th 2021The National Medical Products Administration in China has approved pembrolizumab for use in combination with platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic esophageal carcinoma or gastroesophageal junction cancer.
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ESMO Publishes Guidelines for the Management of Solid Tumor Brain Metastases
September 7th 2021The European Association of Neuro-Oncology and ESMO have released clinical practice guidelines, which provide management recommendations for the diagnosis, treatment, and follow-up of patients with solid tumor brain metastases.
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EMA Validates Applications for Nivolumab/Ipilimumab, Nivolumab/Chemo in Frontline ESCC
August 17th 2021The European Medicines Agency has validated its Type II Variation Marketing Authorization Applications for nivolumab plus ipilimumab and nivolumab plus fluoropyrimidine- and platinum-containing chemotherapy as frontline options for adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma.
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NICE Recommends Abemaciclib for HR+/HER2– Advanced Breast Cancer
August 12th 2021The United Kingdom’s National Institute for Health and Care Excellence has issued draft guidance supporting the use of abemaciclib in the treatment of adult patients with metastatic hormone receptor–positive/HER2-negative breast cancer.
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Utility of Immunotherapy Keeps Evolving in Unresectable Stage III NSCLC
July 31st 2021Many checkpoint inhibitors are currently under investigation in combination with concurrent radiotherapy in stage III non–small cell lung cancer, which experts propose could have practice-changing implications.
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Adjuvant Nivolumab Approved in Europe for Select Esophageal or GEJ Cancers
July 30th 2021The European Commission has approved nivolumab for use as an adjuvant treatment in adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease after neoadjuvant chemoradiation.
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Nivolumab/Ipilimumab Approved in Europe for dMMR or MSI-H Metastatic Colorectal Cancer
June 29th 2021The European Commission has approved the combination of nivolumab plus ipilimumab for use in adult patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer following previous fluoropyrimidine-based combination chemotherapy.
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Pembrolizumab/Chemo Approved in Europe for Select Esophageal Cancer or HER2– GEJ Adenocarcinoma
June 29th 2021The European Commission has approved pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or HER2-negative gastroesophageal junction adenocarcinoma whose tumors have PD-L1 expression.
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EU Panel Recommends Adjuvant Nivolumab for Select Esophageal, GEJ Cancers
June 25th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease after previous neoadjuvant chemoradiotherapy.
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