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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CHMP Advises Against Adagrasib Approval for KRAS G12C–Mutant Advanced NSCLC
July 24th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the conditional marketing authorization application for adagrasib for the treatment of patients with KRAS G12C–mutated advanced non–small cell lung cancer.
JZP458 Receives CHMP Recommendation for Approval in ALL, Lymphoblastic Lymphoma
July 21st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of JZP458 for use in combination with multi-agent chemotherapy for the treatment of adult and pediatric patients 1 month and older with acute lymphoblastic leukemia and lymphoblastic lymphoma who developed hypersensitivity or silent inactivation to Escherichia coli–derived asparaginase.
Teclistamab Snags Positive CHMP Opinion for Relapsed/Refractory Multiple Myeloma
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of a Type II variation for teclistamab in the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies.
CHMP Recommends Talquetamab Monotherapy for R/R Multiple Myeloma
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended conditional marketing authorization of talquetamab for use as a single agent in adult patients with relapsed or refractory multiple myeloma who have previously received at least 3 therapies.
Adjuvant Nivolumab Receives CHMP Recommendation for Completely Resected Stage IIB/C Melanoma
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of nivolumab monotherapy for the adjuvant treatment of patients at least 12 years of age with completely resected stage IIB or IIC melanoma.
Epcoritamab Approaches EU Approval for Relapsed/Refractory DLBCL
The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending conditional marketing authorization to epcoritamab monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma after 2 or more lines of systemic therapy.
China’s NMPA Accepts sNDA for First-Line Toripalimab Plus Chemo in ES-SCLC
China’s National Medical Products Administration has accepted a supplemental new drug application seeking the approval of toripalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with extensive-stage small cell lung cancer.
EMA Accepts Marketing Application for Zolbetuximab in CLDN18.2+ Gastric/GEJ Adenocarcinoma
The European Medicines Agency has accepted a marketing authorization application seeking the approval of zolbetuximab for first-line treatment of patients with Claudin18.2-positive, HER2-negative, unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
China’s NMPA Accepts sNDA for Frontline Toripalimab Plus Axitinib in Metastatic RCC
China’s National Medical Products Administration has accepted a supplemental new drug application seeking the approval of toripalimab plus for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma
Trastuzumab Deruxtecan Approved in China for HER2-Low Metastatic Breast Cancer
China’s National Medical Products Administration has approved trastuzumab deruxtecan monotherapy in adult patients with unresectable or metastatic HER2-low breast cancer who have previously received a systemic therapy in the metastatic setting or whose disease recurred during or within 6 months of adjuvant chemotherapy.
Fixed-Duration Glofitamab Approved in Europe for Relapsed/Refractory DLBCL
The European Commission has granted conditional marketing authorization to glofitamab for fixed-duration administration in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following 2 or more lines of systemic treatment.
Equecabtagene Autoleucel Approved in China for Relapsed/Refractory Multiple Myeloma
China’s National Medical Products Administration has approved the new drug application for equecabtagene autoleucel for the treatment of adult patients with relapsed or refractory multiple myeloma who previously received 3 or more lines of therapy, including a proteasome inhibitor and an immunomodulatory drug.
Neoadjuvant Nivolumab/Chemo Wins EU Approval for Resectable PD-L1+ NSCLC
The European Commission has approved nivolumab in combination with platinum-based chemotherapy for the neoadjuvant treatment of patients with resectable non–small cell lung cancer at high risk of recurrence with tumor cell PD-L1 expression of at least 1%.
Repotrectinib NDA Under NMPA Review for Locally Advanced or Metastatic ROS1+ NSCLC
The National Medical Products Administration in China has accepted for review a new drug application seeking the approval of repotrectinib for use in adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer.
Sacituzumab Govitecan Approaches EU Approval for Pretreated HR+ Metastatic Breast Cancer
The EMA's Committee for Medicinal Products for Human Use has adopted a positive opinion regarding sacituzumab govitecan-hziy monotherapy in select patients with unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer.
European Medicines Agency Validates MAA for Fruquintinib in Pretreated mCRC
June 16th 2023The European Medicines Agency has validated and accepted a marketing authorization application for priority review for fruquintinib for the treatment of adult patients with pretreated metastatic colorectal cancer.
Majority of US Cancer Centers Report Shortages of Cisplatin/Carboplatin Chemotherapy
A survey conducted by the National Comprehensive Cancer Network Best Practices Committee found that 93% of United States cancer centers polled in the report are experiencing a shortage of carboplatin, and 70% currently have a shortage of cisplatin.
EMA Committee Recommends Piflufolastat 18F PSMA PET Imaging Agent for Prostate Cancer
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of piflufolastat 18F, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent, for use in prostate cancer detection.
Olverembatinib Recommended for Breakthrough Therapy Designation in China for SDH-Deficient GIST
The China National Medical Products Adminstration’s Center for Drug Evaluation has recommended that olverembatinib receive breakthrough therapy designation for the treatment of patients with gastrointestinal stromal tumor that is succinate dehydrogenase deficient.
European Approval Sought for Cilta-cel in Relapsed and Lenalidomide-Refractory Myeloma
A Type II variation application seeking the approval of ciltacabtagene autoleucel in adult patients with relapsed and lenalidomide-refractory multiple myeloma has been submitted to the European Medicines Agency.
EMA Recommends Approval of Neoadjuvant Nivolumab/Chemotherapy in Resectable NSCLC
May 26th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab as neoadjuvant therapy in combination with platinum-based chemotherapy for patients with resectable non–small cell lung cancer at high risk of recurrence and tumor cell PD-L1 expression of at least 1%.
Quizartinib Garners Approval in Japan for Newly Diagnosed FLT3-ITD+ AML
Japan’s Ministry of Health, Labour, and Welfare has approved quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation and as maintenance monotherapy in patients with newly diagnosed acute myeloid leukemia whose tumors harbor FLT3-ITD mutations.
China’s NMPA Accepts sNDA for Toripalimab Plus Chemo in Advanced TNBC
The National Medical Products Administration has accepted the supplemental new drug application seeking the approval of toripalimab in combination with nab-paclitaxel in patients with untreated metastatic or recurrent triple-negative breast cancer and a PD-L1 combined positive score of at least 1.
The National Institute for Health and Care Excellence has recommended the combination of pembrolizumab and lenvatinib for use in previously treated patients with advanced or recurrent endometrial cancer whose cancer has progressed on or after platinum-based chemotherapy and who cannot have curative surgery or radiotherapy.
Chinese Phase 3 Trial of Roxadustat in Non-Myeloid Malignancies Meets Primary End Point
Roxadustat proved to be noninferior to recombinant erythropoietin alfa with regard to change in hemoglobin level from baseline to an average level during weeks 9 to 13 in patients receiving concurrent chemotherapy for non-myeloid malignancies in China, meeting the primary end point of an ongoing phase 3 trial.
IBI351 Receives Breakthrough Therapy Designation in China for Previously Treated Advanced CRC
China’s National Medical Products Administration has granted a breakthrough therapy designation to the KRAS G12C inhibitor IBI351 as monotherapy for previously treated patients with advanced colorectal carcinoma harboring a KRAS G12C mutation.
China Approves Zanubrutinib in Previously Untreated CLL/SLL and Waldenström Macroglobulinemia
China’s National Medical Products Administration has approved 2 supplemental new drug applications of zanubrutinib for use in treatment-naïve adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma and Waldenström macroglobulinemia.