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.
European Commission Grants Orphan Drug Designation to Nana-val for Peripheral T-cell Lymphoma
September 8th 2022The European Commission has granted an orphan drug designation to nanatinostat and valganciclovir for use as a potential therapeutic option in patients with peripheral T-cell lymphoma.
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Approval Sought for Tafasitamab/Lenalidomide Combo in R/R DLBCL in Hong Kong
August 31st 2022The Hong Kong Special Administrative Region’s Department of Health has accepted for review a biologics license application seeking the approval of tafasitamab plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma.
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Daiichi Sankyo Submits sNDA for Quizartinib in Newly Diagnosed FLT3-ITD+ AML in Japan
August 30th 2022Daiichi Sankyo submitted a supplemental new drug application to Japan’s Ministry of Health, Labor, and Welfare for the use of quizartinib in patients with newly diagnosed, FLT3-ITD–positive acute myeloid leukemia.
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EU Approves Asciminib for Ph+ CML in Chronic Phase After 2 or More TKIs
August 29th 2022The European Commission has approved asciminib for the treatment of patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase who received prior treatment with at least 2 TKIs
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European Commission Grants Conditional Marketing Authorization to Teclistamab for Multiple Myeloma
August 24th 2022The European Commission has granted conditional marketing authorization to teclistamab for use as a single agent in adult patients with relapsed and refractory multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.
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European Union Green Lights PD-L1 Companion Diagnostic for Adjuvant Atezolizumab in NSCLC
August 24th 2022CE label expansion was granted to the Ventana PD-L1 assay for use as a companion diagnostic to identify patients with non–small cell lung cancer who are eligible for treatment with adjuvant atezolizumab.
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Tislelizumab/Chemo Combo Takes Step Toward Chinese Approval for Unresectable ESCC
August 23rd 2022The China National Medical Products Administration’s Center for Drug Evaluation has accepted for review a supplemental biologics application seeking the approval of tislelizumab plus chemotherapy in the first-line treatment of patients with unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.
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EMA Accepts Marketing Authorization Application for Fixed-Dose Decitabine/Cedazuridine Combo in AML
August 22nd 2022The European Medicines Agency has accepted the marketing authorization application for the oral fixed-dose combination of decitabine and cedazuridine for the frontline treatment of adults with acute myeloid leukemia who are not candidates for standard induction chemotherapy.
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EMA Accepts Marketing Authorization Application for Elacestrant in ER+/HER2- Advanced Breast Cancer
August 22nd 2022The European Medicines Agency has validated a marketing authorization application for elacestrant for estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer.
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The United Kingdom Medicines and Healthcare Products Regulatory Agency has extended the conditional marketing authorization of fam-trastuzumab deruxtecan-nxki for single-agent use in adult patients in Great Britain who have HER2-positive unresectable or metastatic breast cancer and have received 1 or more prior HER2-based regimens.
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European Commission Approves Melphalan Flufenamide for Relapsed/Refractory Multiple Myeloma
August 18th 2022The European Commission has approved melphalan flufenamide for use in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 3 prior therapies.
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Sintilimab Combo Extends PFS in Previously Treated EGFR-Mutated NSCLC
August 3rd 2022Sintilimab in combination with a bevacizumab biosimilar plus pemetrexed and cisplatin induced a progression-free survival benefit of 2.6 months compared with chemotherapy alone for patients with EGFR-mutated, locally advanced or metastatic non–small cell lung cancer, according to interim findings from the ongoing phase 3 ORIENT-31 trial.
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Ropeginterferon Alfa-2b Proves to be Efficacious, Safe in Japanese Patients with Polycythemia Vera
August 2nd 2022Ropeginterferon alfa-2b produced durable complete hematologic responses without phlebotomy and showcased a consistent safety profile in Japanese patients with polycythemia vera, according to findings from a phase 2 study (NCT04182100) presented during the 2022 EHA Congress.
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Relatlimab Plus Nivolumab Approaches EU Approval for Advanced Melanoma With PD-L1 of <1%
July 23rd 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of the fixed-dose combination of nivolumab and relatlimab for the frontline treatment of adult and adolescents who are 12 years of age or older with advanced melanoma and a tumor cell PD-L1 expression of less than 1%.
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Eltanexor Gets FDA Fast Track Status and Orphan Medicinal Product Designation in Europe for MDS
July 21st 2022Eltanexor has been granted a fast track designation from the FDA and an orphan medicinal product designation from the European Commission for use as a potential therapeutic option in patients with myelodysplastic syndromes.
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Selinexor Combo Approved in Europe for Multiple Myeloma After at Least 1 Prior Therapy
July 21st 2022The European Commission granted a full marketing authorization to selinexor in combination with once-weekly bortezomib and low-dose dexamethasone for the treatment of adults with multiple myeloma who have received at least 1 previous therapy.
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Axi-cel Gains European Approval for Relapsed/Refractory Follicular Lymphoma
June 28th 2022The European Commission has granted approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed/refractory follicular lymphoma after 3 or more prior lines of systemic therapy.
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Olaparib Approaches EU Approval for BRCA+, High-Risk Early Breast Cancer
June 27th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of olaparib for the adjuvant treatment of patients with germline BRCA-mutated, HER2-negative, high-risk, early breast cancer who have received neoadjuvant or adjuvant chemotherapy.
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Asciminib Moves Toward EU Approval for Ph+ CML in Chronic Phase
June 24th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorization for asciminib for the treatment of adult patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase who were previously treated with at least 2 TKIs.
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CHMP Recommends Melphalan Flufenamide for Triple-Class Refractory Multiple Myeloma
June 23rd 2022The European Medicines Agency's Committee for Medicinal Products for Human Use has unanimously recommended full marketing authorization approval of melphalan flufenamide for patients with triple-class refractory multiple myeloma.
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Capmatinib Approved in Europe for METex14-Altered Advanced NSCLC
June 22nd 2022The European Commission has approved capmatinib as a single agent for the treatment of patients with MET exon14 skipping–altered advanced non–small cell lung cancer who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
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European Medicines Agency Validates Type II Variation Application for Liso-cel in Second-line LBCL
June 20th 2022The European Medicines Agency has verified its type II variation application to extend the indication for lisocabtagene maraleucel to include the treatment of adult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma, who are refractory or have relapsed within 12 months of initial therapy and are candidates for hematopoietic stem cell transplant.
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Repotrectinib Receives Breakthrough Therapy Designations in China for ROS1+ NSCLC
June 17th 2022The China National Medical Products Administration’s Center for Drug Evaluation granted 2 breakthrough therapy designations to repotrectinib for the treatment of patients with ROS1-positive metastatic non–small cell lung cancer.
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