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.
May 8th 2024
China's NMPA has granted breakthrough therapy designation to IBI343 for use in select patients with claudin 18.2–positive gastric or GEJ adenocarcinoma.
Show Me Your Care Plan™: Nursing Considerations for Applying the Latest Approaches Across Care Settings in Melanoma
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Patient, Provider and Caregiver Connection™: Addressing Patient Concerns During the Treatment and Management of HR+/HER2- Breast Cancer
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Breaking Down Biomarkers in Non–Small Cell Lung Cancer: A Case-Based Discussion for the Oncology Nurse
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Medical Crossfire®: Critical Questions on Diagnosis, Sequencing, and Selection of Systemic and Radioligand Therapy Options for Patients with GEP-NETs
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Medical Crossfire®: Expert Exchanges to Maximize Clinical Outcomes for Patients with CRPC Through Evidence-Based Personalized Therapy
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Community Practice Connections™: 16th Annual Interdisciplinary Prostate Cancer Congress® and Other Genitourinary Malignancies
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Patient, Provider, and Caregiver Connection: Addressing Pediatric and AYA Patient Concerns While Managing Hodgkin Lymphoma
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Go To PER in Chicago
May 31, 2024 - June 2, 2024
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The Top 10 Oncogenic Drivers in NSCLC for 2023: What You Need to Know on Tumor Testing, Targets, and Treatment Strategies to Move the Field Forward
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Patient, Provider, and Caregiver Connection™: Individualizing Care for Patients with Schizophrenia—Understanding Patient Challenges and the Role of Innovative Treatment
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Expert Illustrations & Commentaries™: Exploring the Mechanistic Rationale for Targeting FGFR2 and Pan-FGFR in CCA
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Improving Outcomes in Autoimmune Hemolytic Anemias at the Intersection Between Hematology and Oncology Care
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Oncology Consultations®: Next Generation SERDs—Key Data and Practical Takeaways for the Community Physician
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Live “Hot Seat”: Experts Face Your Hot-Button Questions on Maximizing PARP Inhibitors in Patients With CRPC
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Medical Crossfire®: Leveraging Multidisciplinary Teams in Early–Stage Breast Cancer When the Goal is Cure
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Everything You Need to Know About PARP Inhibitor Combinations in Prostate Cancer Care: Why? For Whom? And When?
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Expanding the Armamentarium of Actionable Mutations in NSCLC: Uncovering the Potential of CEACAM5 as a Therapeutic Target
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Multidisciplinary Management of TNBC: Immunotherapy, PARP, TROP2, Oh My!
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The 14th Asia-Pacific Primary Liver Cancer Expert Meeting
July 18 - 20, 2024
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23rd Annual International Congress on the Future of Breast Cancer® East
July 19-20, 2024
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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™: 8th Annual School of Gastrointestinal Oncology®
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Community Practice Connections™: The Advent of TROP2-Targeted Treatment Approaches in HR+/HER2- Breast Cancer
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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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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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Cancer Summaries and Commentaries™: Clinical Updates from Chicago in Breast Cancer
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8th Annual School of Nursing Oncology™
August 10, 2024
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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.
Liso-cel Earns European Approval for Relapsed/Refractory LBCL After 1 Prior Therapy
The European Commission has approved lisocabtagene maraleucel for the treatment of adult patients with diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
First-line Cemiplimab Plus Chemo Wins Approval in Canada for Advanced NSCLC
Health Canada has approved the combination of cemiplimab and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic non–small cell lung cancer without EGFR, ALK, or ROS1 aberrations who are not candidates for definitive chemoradiation.
Niraparib/Abiraterone Acetate Combo Approved in Europe for BRCA1/2+ mCRPC
The European Commission has granted marketing authorization to the dual action tablet comprised of niraparib and abiraterone acetate to be administered with prednisone or prednisolone in adult patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated.
HECTOR Deep Learning Model Shows Predictability for Distant Recurrence Risk in Endometrial Cancer
A deep learning risk prediction model was able to accurately identify patients with endometrial cancer at low and high risk of distant recurrence, according to data presented during the 2023 AACR Annual Meeting.
Adjuvant Atezolizumab Plus Bevacizumab Significantly Improves RFS in High-risk HCC
Adjuvant treatment with the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) resulted in a statistically significant and clinically meaningful improvement in recurrence-free survival vs active surveillance in patients with a high risk of hepatocellular carcinoma recurrence following curative-intent resection or ablation.
EMA Awards PRIME Scheme Designation to mRNA-4157/V940 Plus Pembrolizumab in High-risk Melanoma
The European Medicines Agency has granted Priority Medicines scheme designation to the personalized cancer vaccine mRNA-4157/V940 and pembrolizumab for use as adjuvant treatment in patients with high-risk, stage III or IV melanoma following complete resection.
NICE Guidance Supports Olaparib Use in BRCA-Mutant Breast, Prostate Cancer
The National Institute for Health and Care Excellence announced final draft guidance recommending the PARP inhibitor olaparib for patients with HER2-negative, high-risk early breast cancer harboring a BRCA1/2 mutation, as well as for those with previously treated hormone-relapsed metastatic prostate cancer with a BRCA1/2 mutation.
Liso-cel Receives European Approval Recommendation for Relapsed/Refractory LBCL
March 31st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of lisocabtagene maraleucel for the treatment of select patients with large B-cell lymphoma who relapsed within 12 months from completion of or developed refractory disease to frontline chemoimmunotherapy.
European Commission Approves Cemiplimab Plus Chemotherapy for First-line PD-L1+ NSCLC
March 29th 2023The European Commission has approved cemiplimab-rwlc plus platinum-based chemotherapy for the frontline treatment of patients with locally advanced or metastatic PD-L1–positive non–small cell lung cancer without EGFR, ALK, or ROS1 alterations and who are not eligible for chemoradiation.
Fixed-Duration Ibrutinib Plus Venetoclax Earns Approval in Canada for Previously Untreated CLL
Canada Health has approved the fixed-duration, all-oral combination of ibrutinib and venetoclax for the frontline treatment of adult patients with chronic lymphocytic leukemia, including those with 17p deletion.
Trastuzumab Deruxtecan Garners Approval in Japan for HER2-Low Metastatic Breast Cancer
Japan’s Ministry of Health, Labor and Welfare has approved fam-trastuzumab deruxtecan-nxki for the treatment of adult patients with HER2-low unresectable or recurrent breast cancer after prior chemotherapy.
Acalabrutinib Receives Approval in China for Relapsed/Refractory Mantle Cell Lymphoma
March 23rd 2023Acalabrutinib has received conditional approval from the National Medical Products Administration in China for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
China ARCHES Study Meets Primary, Secondary End Points in Metastatic Prostate Cancer
March 14th 2023Enzalutamide plus androgen deprivation therapy produced a statistically significant improvement in time to prostate-specific antigen progression compared with ADT and placebo in men with metastatic hormone-sensitive prostate cancer, meeting the primary end point of the phase 3 China ARCHES study.