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.
July 26th 2024
The EMA's CHMP has recommended zolbetuximab plus chemotherapy in select locally advanced unresectable or metastatic HER2-negative gastric or GEJ cancer.
Community Practice Connections™: 14th Annual International Symposium on Ovarian Cancer and Other Gynecologic Malignancies
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Advances In™: Targeting PSMA to Advance Diagnosis And Management Of Patients With Prostate Cancer
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Clinical Case Vignette Series: Integrating Recent Data into Practice to Improve Outcomes in Advanced Prostate Cancer
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Community Practice Connections™: The Advent of TROP2-Targeted Treatment Approaches in HR+/HER2- Breast Cancer
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Cancer Summaries and Commentaries™: Clinical Updates from Chicago in Breast Cancer
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Community Practice Connections™: 8th Annual School of Gastrointestinal Oncology®
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B-Cell Tumor Board: Rendering Real World Personalized Treatment Plans in CLL/SLL and MCL Through the Lens of Emerging BTKi Evidence
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Show Me the Data™: Do We Have Sea Change for Novel Approaches in HR+/HER2- Breast Cancer? CDK, PI3K/AKT, ADC, and Next-Gen SERD Strategies Assessed
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Community Practice Connections™: Controversies and Conversations About HER2- Expressing Breast Cancer…Advances in Management of HER2-Low to -Positive Disease
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8th Annual School of Nursing Oncology™
August 10, 2024
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7th Annual Live Medical Crossfire®: Hematologic Malignancies
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Cancer Summaries and Commentaries™: Clinical Updates in RCC from Chicago
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Community Practice Connections™: Integrating BTK Inhibitors Into the CLL/SLL and MCL Treatment Paradigm
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Community Practice Connections™: 7th Annual International Congress on Oncology Pathology
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Community Practice Connections™: What the Community Needs to Know to Apply RLT in PSMA-Positive mCRPC in Context with Current Treatment Paradigms
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San Diego Lung Symposia
September 7, 2024 - September 8, 2024
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Pathology Implications for CEACAM5 as a Therapeutic Target in Advanced NSCLC
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Medical Crossfire®: What Are Effective Strategies for Onco-Nurses to Improve Outcomes in Patients with Small Cell Lung Cancer?
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2023 ASCO Direct™ Highlights: Practice-Changing Data From the Leading Oncology Conference
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Taking a Critical Look at Healthcare Inequity Among Patients with Cancer: What Role Do Onco-Nurses Play?
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Neoadjuvant Immunotherapy in Melanoma: Where We Are, and Where We Aren’t
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2024 International Symposium of Gastrointestinal Oncology (ISGIO)
October 11-12, 2024
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Virtual Show Me the Data™: How HER2, HER3, and TROP2 Targeted Strategies Will Impact Evolving Paradigms in NSCLC
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Applying New Evidence in Multiple Myeloma Care from Frontline to R/R Disease
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42nd Annual CFS®: Innovative Cancer Therapy for Tomorrow®
November 13-15, 2024
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Community Practice Connections™: 5th Annual Precision Medicine Symposium – An Illustrated Tumor Board
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Community Practice Connections™: Clinical Updates from Chicago – A Focus on What Community Centers Need to Know to Move Their Solid Tumors' Practices Forward
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Tumor Agnostic Trials and the Reshaping of Precision Medicine in Oncology: A Focus on TSC1/2 Mutations
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Medical Crossfire®: How Does Recent Evidence on PARP Inhibitors and Combinations Inform Treatment Planning for Prostate Cancer Now and In the Future?
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Medical Crossfire®: How Do Clinicians Integrate the Latest Evidence in Treating Ovarian Cancer to Personalize Care?
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Trastuzumab Biosimilar Receives CHMP Recommendation for HER2+ Breast and Gastric Cancer
The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization of EirGenix’s biosimilar for trastuzumab for the treatment of patients with HER2-positive breast and metastatic gastric cancers.
CHMP Releases Positive Opinion for Quizartinib in Newly Diagnosed FLT3-ITD+ AML
September 15th 2023The Committee for Medicinal Products for Human Use has recommended the approval of quizartinib in the European Union for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation chemotherapy, followed by maintenance quizartinib, for adult patients with newly diagnosed, FLT3-ITD–positive acute myeloid leukemia.
Trastuzumab Deruxtecan Receives CHMP Recommendation for Approval in HER2-Mutant NSCLC
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended fam-trastuzumab deruxtecan-nxki for use as a single agent in adult patients with HER2-mutated, advanced non–small cell lung cancer who require systemic treatment after platinum-based chemotherapy with or without immunotherapy.
Adjuvant Pembrolizumab Receives Positive CHMP Opinion for High-Risk NSCLC After Resection and Chemo
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab as adjuvant treatment for adult patients with non–small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
Extended Melphalan Flufenamide Indication Approaches EU Approval for R/R Multiple Myeloma
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding a Type II variation application to extend the therapeutic indication of melphalan flufenamide for use in adult patients with multiple myeloma who have received at least 2 prior lines of treatment and whose disease is refractory to lenalidomide and the last line of therapy.
Golidocitinib NDA Under NMPA Review for Relapsed/Refractory PTCL
The Center for Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application seeking the approval of golidocitinib for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma.
A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of erdafitinib for the treatment of adult patients with locally advanced, unresectable or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who experienced disease progression during or following at least 1 line of therapy containing a PD-1/PD-L1 inhibitor.
The addition of durvalumab to chemotherapy prior to surgery, followed by adjuvant durvalumab, did not provide a clear clinical benefit in patients with early-stage non–small cell lung cancer harboring an EGFR mutation, according to data from the phase 3 AEGEAN trial.
Repotrectinib Gets Breakthrough Therapy Designation in China for NTRK+ TKI-Pretreated Solid Tumors
The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted breakthrough therapy designation to repotrectinib for use in patients with advanced solid tumors harboring a NTRK gene fusion who experienced disease progression after TKI treatment.
Savolitinib Wins Breakthrough Therapy Designation in China for Gastric Cancer With MET Amplification
The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted a breakthrough therapy designation to savolitinib for use in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction with MET amplification in whom at least 2 lines of standard therapy have failed.
Subcutaneous Atezolizumab Approved in Great Britain for All Intravenous Indications
Great Britain’s Medicines and Healthcare Products Regulatory Agency has approved subcutaneous atezolizumab for all indications in which the intravenous formulation of the drug has been approved, including select types of lung, bladder, breast, and liver cancers.
Olaparib Plus Abiraterone Acetate Receives Japanese Approval for BRCA-Mutant mCRPC
August 24th 2023The Japanese Ministry of Health, Labour, and Welfare has approved the combination of olaparib plus abiraterone acetate and prednisone or prednisolone for the treatment of adult patients with BRCA-mutated castration-resistant prostate cancer with distant metastasis.
Sunvozertinib Approved in China for NSCLC With EGFR Exon 20 Insertion Mutations
The National Medical Products Administration of China has approved sunvozertinib for use in adult patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations whose disease has progressed on or following platinum-based chemotherapy.
Trastuzumab Deruxtecan Approved in Japan for HER2-Mutated Metastatic NSCLC
Japan’s Ministry of Health, Labour, and Welfare has approved fam-trastuzumab deruxtecan-nxki for use in adult patients with unresectable advanced or recurrent, HER2-mutant non–small cell lung cancer that has progressed following chemotherapy.
Adjuvant Nivolumab Approved in Europe for Completely Resected Stage IIB or IIC Melanoma
The European Commission has approved single-agent nivolumab for use in the adjuvant treatment of adult and adolescent patients aged 12 years or older who have stage IIB or IIC melanoma and who have undergone complete resection.
Talquetamab Wins Approval in Europe for Relapsed/Refractory Myeloma
The European Commission has granted conditional marketing authorization to talquetamab-tgvs monotherapy for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 3 prior therapies and have demonstrated disease progression on the last therapy.
European Commission Approves Reduced Dosing of Teclistamab in Relapsed/Refractory Myeloma
The European Commission has approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5 mg/kg every 2 weeks in patients with relapsed/refractory multiple myeloma who have achieved a complete response or better for a minimum of 6 months.
EMA Accepts Marketing Application for Odronextamab in R/R DLBCL or Follicular Lymphoma
The European Medicines Agency has accepted a marketing authorization application seeking the approval of odronextamab for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma who have progressed after at least 2 prior systemic therapies.
BAT8006 Elicits Disease Control, Safety in Advanced Ovarian Cancer and Other Solid Tumors
Treatment with the folate receptor–α antibody-drug conjugate BAT8006 led to responses with a manageable safety profile in patients with advanced solid tumors, including ovarian cancer, breast cancer, and cervical cancer.
China’s Center for Drug Evaluation of the National Medical Products Administration has granted a breakthrough therapy designation to glecirasib for the treatment of patients with pancreatic cancer harboring a KRAS G12C mutation and who have progressed after frontline standard-of-care treatment.
Loncastuximab Tesirine BLA Receives Priority Review in China for Relapsed/Refractory DLBCL
July 24th 2023The China National Medical Products Administration has accepted and granted priority review to the biologics license application seeking the approval of loncastuximab tesirine-lpyl for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma following at least 2 prior lines of systemic therapy.