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.
KTE-X19 Approved in Europe for Relapsed/Refractory MCL
December 17th 2020December 17, 2020 — The European Commission has granted a conditional marketing authorization to the CD19-targeted CAR T-cell therapy KTE-X19 for use in adult patients with relapsed or refractory mantle cell lymphoma who had previously received 2 or more lines of systemic therapy including a BTK inhibitor.
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Fixed-Dose Durvalumab Nears EU Approval for Unresectable NSCLC
December 15th 2020December 15, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for an additional dosing option of durvalumab, a fixed dose of 1500 mg every 4 weeks, in the approved indication of locally advanced, unresectable non–small cell lung cancer in adults whose tumors have a PD-L1 expression of at least 1% and who did not have progressive disease after platinum-based chemoradiation treatment.
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December 11, 2020 - The European Medicine Agency’ s Committee for Medicinal Products for Human Use has granted a positive opinion to avelumab as a single agent, frontline maintenance option for adult patients with locally advanced or metastatic urothelial carcinoma who are free of disease progression after platinum-based chemotherapy.
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EU Panel Recommends Tucatinib for Locally Advanced or Metastatic HER2+ Breast Cancer
December 11th 2020December 11, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to tucatinib in combination with trastuzumab and capecitabine for use in adult patients with HER2-positive, locally advanced or metastatic breast cancer who had received at least 2 previous anti-HER2 therapies.
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Frontline Pembrolizumab Granted Positive EU Opinion in Metastatic MSI-H, dMMR CRC
December 11th 2020December 11, 2020 - The European Medicine Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for pembrolizumab monotherapy for the frontline treatment of adult patients with metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer.
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Ipatasertib/Paclitaxel Fails to Improve PFS in PIK3CA/AKT1/PTEN-Altered TNBC
December 10th 2020December 10, 2020 — The combination of ipatasertib and paclitaxel failed to show a significant improvement in progression-free survival vs placebo plus paclitaxel in patients with PIK3CA/AKT1/PTEN-altered locally advanced, unresectable or metastatic triple-negative breast cancer.
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Ki-67 Can Be Used to Select Abemaciclib for Patients With High-Risk Early Breast Cancer
December 10th 2020December 10, 2020 - Treatment with abemaciclib in combination with endocrine therapy significantly reduced the risk of invasive disease recurrence or death in patients with hormone receptor–positive, HER2-negative, node-positive, early breast cancer who had high Ki-67 tumors, suggesting that this feature can be used in conjunction with high-risk features to select patients for abemaciclib in the adjuvant setting.
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Oxidative Stress, Antioxidant Status Remain High in Nigerian Patients With Prostate Cancer
December 4th 2020Nigerian patients with prostate cancer are noted as having higher levels of total plasma peroxide, malondialdehyde, and nitric oxide, as well as lower levels of total antioxidant capacity, even while undergoing androgen-deprivation therapy compared with Nigerian men who don't have prostate cancer.
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Regulatory applications have been submitted to the FDA and the European Medicines Agency for subcutaneous daratumumab for use in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least 1 previous therapy.
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Enzalutamide Approved in China for Nonmetastatic Castration-Resistant Prostate Cancer
November 11th 2020November 10, 2020 - The China National Medical Products Administration has approved enzalutamide for the treatment of adult patients with nonmetastatic castration-resistant prostate cancer who are at a higher risk of metastasis.
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Nivolumab/Ipilimumab Plus Chemo Approved in Europe for Frontline Metastatic NSCLC
November 6th 2020The European Commission has approved the combination of nivolumab plus ipilimumab with 2 cycles of platinum-based chemotherapy for the up-front treatment of adult patients with metastatic non–small cell lung cancer without a sensitizing EGFR mutation or an ALK translocation.
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Olaparib/Bevacizumab Approved in Europe for Frontline Maintenance in HRD+ Advanced Ovarian Cancer
November 5th 2020The European Union has approved olaparib in combination with bevacizumab for use as a first-line maintenance treatment in patients with homologous recombination deficient–positive advanced ovarian cancer.
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Atezolizumab/Bevacizumab Approved in Europe for Advanced or Unresectable HCC
November 2nd 2020The European Commission has approved the combination of atezolizumab plus bevacizumab for use in adult patients with advanced or unresectable hepatocellular carcinoma who have not been given previous systemic therapy.
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Atezolizumab Plus Bevacizumab Approved in China for Hepatocellular Carcinoma
October 30th 2020The China National Medical Products Administration has approved the combination of atezolizumab plus bevacizumab for use in patients with unresectable hepatocellular carcinoma who have not received previous systemic therapy.
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Niraparib Approved in Europe for Frontline Maintenance in Advanced Ovarian Cancer
October 29th 2020The European Commission has approved niraparib for use as a frontline monotherapy maintenance option in adult patients with advanced epithelial, high-grade ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response after platinum-based chemotherapy.
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Approval Sought for Cabozantinib/Nivolumab for Unresectable, Advanced, or Metastatic RCC in Japan
October 27th 2020A supplemental application was submitted to the Japanese Ministry of Health, Labour, and Welfare for Manufacturing and Marketing approval of the combination of cabozantinib plus nivolumab for the treatment of patients with unresectable, advanced, or metastatic renal cell carcinoma.
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