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 2022The 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.
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Zanubrutinib Applications for CLL and MZL Accepted for Review in Europe
February 23rd 2022The 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.
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Tepotinib Approved in Europe for METex14-Altered Advanced NSCLC
February 21st 2022The 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.
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Frontline Niraparib Plus Abiraterone Improves rPFS in HRR Gene–Altered mCRPC
February 17th 2022The 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.
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Pelareorep/Atezolizumab Plus Chemo Shows Early Safety in Frontline Metastatic Pancreatic Cancer
February 3rd 2022The 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.
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Zanubrutinib sNDA for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Accepted in China
February 1st 2022The 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.
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European Approval Sought for Teclistamab in Relapsed/Refractory Multiple Myeloma
February 1st 2022A 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.
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EU Panel Recommends Avapritinib for Advanced Systemic Mastocytosis
January 31st 2022The 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.
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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.
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Lorlatinib Approved in Europe for ALK+ Advanced NSCLC
January 28th 2022The 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.
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Key Markers in Gut Microbiome May Predict Skin-Related AEs With Nivolumab in Advanced Gastric Cancer
January 20th 2022The 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.
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Idecabtagene Vicleucel Approved in Japan for Relapsed/Refractory Multiple Myeloma
January 20th 2022The 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.
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NHS Scotland Accepts Trastuzumab Deruxtecan for Use in HER2+ Metastatic Breast Cancer
January 17th 2022The 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.
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Japanese Approval Sought for Valemetostat in Relapsed/Refractory Adult T-Cell Leukemia/Lymphoma
January 3rd 2022A 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.
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Pembrolizumab/Lenvatinib Approved in Japan for Endometrial Cancer Following Progression on Chemo
January 3rd 2022The 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.
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Selinexor Approved in China for Relapsed or Refractory Multiple Myeloma
December 22nd 2021The 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.
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Japanese Approval Sought for Trastuzumab Deruxtecan in HER2+ Metastatic Breast Cancer
December 21st 2021A 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.
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EU Panel Recommends Adjuvant Pembrolizumab for Select RCC Following Surgery
December 17th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of single-agent pembrolizumab for use as an adjuvant treatment in adult patients with renal cell carcinoma who are at increased risk of recurrence after nephrectomy, or following nephrectomy and the resection of metastatic lesions.
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Enfortumab Vedotin Approaches EU Approval for Locally Advanced or Metastatic Urothelial Cancer
December 17th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of the approval of enfortumab vedotin as a monotherapy in the treatment of adult patients with locally advanced or metastatic urothelial cancer.
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Niraparib Demonstrates PFS Benefit in Chinese Population With Advanced Ovarian Cancer
November 30th 2021First-line maintenance treatment with the PARP inhibitor niraparib yielded a clinically meaningful and statistically significant improvement in progression-free survival vs placebo in Chinese patients with platinum-responsive advanced ovarian cancer, regardless of biomarker status, according to data from the phase 3 PRIME trial.
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Pembrolizumab/Axitinib Improves Outcomes in Japanese mRCC Subgroup
November 30th 2021The combination of pembrolizumab and axitinib demonstrated comparable activity and safety vs sunitinib in Japanese patients vs the global population of patients with newly diagnosed metastatic renal cell carcinoma enrolled in the phase 3 KEYNOTE-426 trial.
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European Commission Approves Pembrolizumab/Lenvatinib for Advanced or Recurrent Endometrial Cancer
November 29th 2021The European Commission has granted an approval to the combination of pembrolizumab and lenvatinib for the treatment of patients with advanced or recurrent endometrial carcinoma who have disease progression on or following prior platinum-containing therapy in any setting and who are not eligible for curative surgery or radiation.
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Sacituzumab Govitecan Approved in Europe for Second-Line Metastatic TNBC
November 23rd 2021The European Commission granted marketing authorization for sacituzumab govitecan-hziy for use as a monotherapy in the treatment of adult patients with unresectable or metastatic triple-negative breast cancer who have previously received 2 or more systemic therapies, at least 1 of them for advanced disease.
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Pralsetinib Approved in Europe for RET Fusion+ Advanced NSCLC
November 19th 2021The European Commission has granted a conditional marketing authorization to pralsetinib for use as a single agent in adult patient with RET fusion–positive advanced non–small cell lung cancer who did not previously receive a RET inhibitor.
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Sotorasib Approaches EU Approval for KRAS G12C–Mutated Advanced NSCLC
November 12th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the conditional marketing authorization of sotorasib for the treatment of adult patients with advanced non–small cell lung cancer whose tumors harbor a KRAS G12C mutation and who have progressed after at least 1 prior line of systemic therapy.
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