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 15th 2024
Olaparib, durvalumab, and fulvestrant produced a 66.7% 24-week PFS rate in patients with endocrine-resistant, ER-positive, HER2-negative breast cancer.
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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Community Practice Connections™: 16th Annual Interdisciplinary Prostate Cancer Congress® and Other Genitourinary Malignancies
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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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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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Live “Hot Seat”: Experts Face Your Hot-Button Questions on Maximizing PARP Inhibitors in Patients With CRPC
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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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Oncology Consultations®: Next Generation SERDs—Key Data and Practical Takeaways for the Community Physician
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Multidisciplinary Management of TNBC: Immunotherapy, PARP, TROP2, Oh My!
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Medical Crossfire®: Leveraging Multidisciplinary Teams in Early–Stage Breast Cancer When the Goal is Cure
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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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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™: The Advent of TROP2-Targeted Treatment Approaches in HR+/HER2- Breast Cancer
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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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Community Practice Connections™: 8th Annual School of Gastrointestinal Oncology®
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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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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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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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7th Annual Live Medical Crossfire®: Hematologic Malignancies
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Pembrolizumab Moves Toward EU Approval for Resected Stage IIB/IIC Melanoma
May 20th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab for use as adjuvant therapy in adult and adolescent patients aged 12 years and older with stage IIB or IIC melanoma following complete resection.
European Approval Sought for Adagrasib in Previously Treated KRAS G12C–Mutated NSCLC
A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of adagrasib for therapeutic use in previously treated patients with non–small cell lung cancer harboring a KRAS G12C mutation.
Selinexor Combo Approaches EU Approval for Refractory Multiple Myeloma
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of selinexor in combination with bortezomib and low-dose dexamethasone for use in adult patients with multiple myeloma who have previously received 1 to 3 prior lines of treatment.
Tisagenlecleucel Approved in Europe for Relapsed/Refractory Follicular Lymphoma
The European Commission has approved the CD19-targeting chimeric antigen receptor T-cell agent tisagenlecleucel for the treatment of adults with relapsed/refractory follicular lymphoma following at least 2 lines of systemic therapy.
The European Commission has approved the use of cabozantinib for use as a single agent in adult patients with locally advanced or metastatic differentiated thyroid carcinoma who are refractory or not eligible to receive radioactive iodine and who have progressed during or following previous systemic treatment.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab alone after surgery for adult patients with locally advanced or early-stage triple-negative breast cancer who are at a high risk for recurrence.
Mosunetuzumab Approaches EU Approval for Relapsed or Refractory Follicular Lymphoma
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval under conditional marketing authorization for mosunetuzumab for use in adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 therapies.
EU Panel Recommends Capmatinib for METex14-Altered Advanced NSCLC
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorization to capmatinib for use as a single agent in select adult patients with advanced non–small cell lung cancer harboring a METex14 skipping alteration.
Adjuvant Atezolizumab Approaches EU Approval for High-Risk NSCLC With PD-L1 of ≥50%
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion supporting the approval of adjuvant atezolizumab, after complete resection and platinum-based chemotherapy, in adult patients with non–small cell lung cancer with a high risk of recurrence and whose tumors express PD-L1 of 50% or higher and do not harbor EGFR mutations or ALK alterations.
Tislelizumab Approved in China for Second-Line Esophageal Squamous Cell Carcinoma
The China National Medical Products Administration has approved tislelizumab for use in patients with locally advanced or metastatic esophageal squamous cell carcinoma who have disease progression or who are intolerant to frontline standard chemotherapy.
NICE Makes Avelumab Available for Maintenance Treatment of Urothelial Cancer
Avelumab is now a treatment option for patients with urothelial cancer in the United Kingdom following a recommendation from the National Institute for Health and Care Excellence issued Thursday, April 7, 2022.1
Relmacabtagene Autoleucel Gets Breakthrough Therapy Designation for MCL in China
The China National Medical Products Administration’s Center for Drug Evaluation has granted a breakthrough therapy designation to relmacabtagene autoleucel for use in the treatment of patients with mantle cell lymphoma.
EMA Accepts Marketing Authorization Applications for Tislelizumab in Select ESCC and NSCLC
Marketing authorization applications seeking the approval of tislelizumab in patients with advanced or metastatic esophageal squamous cell carcinoma following previous systemic chemotherapy and in select patients with non–small cell lung cancer have been submitted to the European Medicines Agency.
Nivolumab/Ipilimumab Approved in Europe for Frontline PD-L1+ Advanced ESCC
The European Commission has approved the dual immunotherapy combination of nivolumab and ipilimumab for use in the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma who had a PD-L1 expression of 1% or higher on tumor cells.
Lisocabtagene Maraleucel Approved in Europe for Select Relapsed/Refractory LBCL
The European Commission has granted marketing authorization to the CD19-directed CAR T-cell therapy lisocabtagene maraleucel for use in 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 treatment.
The European Commission has approved nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy for the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with a PD-L1 expression of 1% or higher on tumor cells.
Adjuvant Nivolumab Approved in Europe for Select High-Risk Muscle-Invasive Urothelial Carcinoma
The European Commission has approved nivolumab for use in the adjuvant treatment of adult patients with muscle-invasive urothelial carcinoma and a PD-L1 expression of 1% or higher on tumor cells, who are at a high risk of recurrence following radical resection.
European Approval Sought for Neoadjuvant Nivolumab/Chemo in Resectable NSCLC
The European Medicines Agency has validated its type II variation application for nivolumab in combination with chemotherapy for use in the neoadjuvant treatment of patients with unresectable stage IB to IIIA non–small cell lung cancer.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab for use in combination with chemotherapy with or without bevacizumab in patients with persistent, recurrent, or metastatic cervical cancer who have a PD-L1 combined positive score of 1 or higher.
Lisocabtagene Maraleucel sNDA for Second-Line Relapsed/Refractory LBCL Accepted for Review in Japan
The Ministry of Health, Labour, and Welfare has accepted a supplemental new drug application for lisocabtagene maraleucel for the second-line treatment of patients with relapsed or refractory large B-cell lymphoma.
Avapritinib Approved in Europe for Advanced Systemic Mastocytosis
The European Commission has expanded the current indication for avapritinib to include use as a single agent in adult patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, or mast cell leukemia, following at least 1 systemic treatment.
CHMP Moves to Recommend Pembrolizumab for MSI-H/dMMR Cancers
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended pembrolizumab for the treatment of adult patients with a variety of microsatellite instability-high or mismatch repair deficient tumors.
Polatuzumab Vedotin Plus R-CHP Recommended for EU Approval for Previously Untreated DLBCL
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of the approval of polatuzumab vedotin for use in combination with rituximab plus cyclophosphamide, doxorubicin, and prednisone in patients with previously untreated diffuse large B-cell lymphoma.
EU Panel Recommends Ruxolitinib for Acute or Chronic Graft-Vs-Host Disease
The European Medicines Agency’s Committee for Medical Products for Human Use has recommended the approval of ruxolitinib for the treatment of patients with acute or chronic graft-vs-host disease who are aged 12 years or older and who have inadequate response to corticosteroids or other systemic therapies.
Tisagenlecleucel Approaches EU Approval for Relapsed/Refractory Follicular Lymphoma
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of tisagenlecleucel for use in adult patients with relapsed/refractory follicular lymphoma following 2 lines of systemic treatment.
FDA Issues Complete Response Letter to Sintilimab/Chemo for Frontline Nonsquamous NSCLC
The FDA has issued a complete response letter to the biologics license application seeking the approval of sintilimab injection in combination with pemetrexed and platinum chemotherapy in the frontline treatment of patients with nonsquamous non–small cell lung cancer.
European Approval Sought for Ivosidenib in IDH1-Mutated AML and Cholangiocarcinoma
A marketing authorization application has been submitted to the European Medicines Agency for 2 indications of ivosidenib: in combination with azacitidine in the frontline treatment of patients with IDH1-mutated acute myeloid leukemia who are not candidates for intensive chemotherapy and in previously treated patients with locally advanced or metastatic IDH1-mutated cholangiocarcinoma.
NICE Rejects Pembrolizumab Plus Chemotherapy for Select Metastatic TNBC
The United Kingdom’s National Institute for Health and Clinical Excellence has issued draft guidance recommending against pembrolizumab plus chemotherapy as a treatment for patients with metastatic triple-negative breast cancer whose tumors express PD-L1 with a combined positive score of 10 or more and who have not received chemotherapy for metastatic disease.