All Oncology News

The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.

LOAd703 Oncolytic Adenovirus Receives FDA Fast Track Designation for Pancreatic Cancer

January 17th 2025

LOAd703 has been granted FDA fast track designation for the treatment of patients with pancreatic cancer.

Zanidatamab Plus Evorpacept Shows Early Activity, Tolerability in Pretreated HER2+ Breast Cancer

January 17th 2025

Alberto Montero, MD, MBA, CPHQ, discusses early signals of efficacy and safety with zanidatamab plus evorpacept in HER2-positive and -low breast cancer.

FDA Approves Sotorasib Plus Panitumumab for KRAS G12C–Mutated Colorectal Cancer

January 16th 2025

The FDA approved sotorasib plus panitumumab for adult select patients with KRAS G12C–mutated metastatic colorectal cancer.

FDA Approves Acalabrutinib Plus Bendamustine and Rituximab for Previously Untreated MCL

January 16th 2025

The FDA has approved acalabrutinib plus bendamustine and rituximab for adult patients with previously untreated MCL who are ineligible for autologous HSCT.

Early Diagnosis and Treatment Are Critical in Achieving the Best Outcomes in Sarcoma

January 16th 2025

Breelyn Wilky, MD, discusses the importance of disease screening and early diagnosis in the treatment of patients with sarcoma.

Obe-Cel Produces Durable Remissions in Adult R/R B-ALL

January 16th 2025

Obe-cel generated durable remissions in patients with relapsed/refractory B-cell acute lymphoblastic leukemia treated during the FELIX trial.

Lete-Cel Receives FDA Breakthrough Therapy Designation for Advanced Myxoid/Round Cell Liposarcoma

January 16th 2025

The FDA granted breakthrough therapy designation to lete-cel for patients with unresectable or metastatic myxoid/round cell liposarcoma.

Dana-Farber and Gustave Roussy Announce 2025 Transatlantic Exchange Scientific Program to Focus on Radioligand Therapy

January 16th 2025

Dana-Farber Cancer Institute and Gustave Roussy have announced that the topic of the Fourth Transatlantic Exchange in Oncology Conference will be “Radiopharmaceutical Therapy Meets Oncology.”

Tabelecleucel BLA Receives FDA CRL in Pretreated EBV+ Post-Transplant Lymphoproliferative Disease

January 16th 2025

The FDA issued a CRL to the BLA of tabelecleucel in EBV+ PTLD following at least 1 prior line of treatment.

EU/UK Approvals Sought for Nogapendekin Alfa Inbakicept Plus BCG in BCG-Unresponsive NMIBC With CIS

January 16th 2025

Nogapendekin alfa inbakicept MAAs have been submitted to the EU's EMA and the UK's MHRA for BCG-unresponsive non–muscle-invasive bladder cancer.

OST-HER2 Meets Primary End Point of Phase 2b Trial in Lung-Only Metastatic Osteosarcoma

January 16th 2025

OST-HER2 shows promise in patients with recurrent, fully resected lung-only metastatic osteosarcoma.

Addition of ASCT to Ibrutinib Plus Rituximab Does Not Confer Benefit in Lower-Risk, Younger MCL

January 16th 2025

Martin Dreyling, MD, PhD, discusses the role of ASCT with or without an ibrutinib-based regimen in younger patients with mantle cell lymphoma.

Zenocutuzumab Addresses High Unmet Need in NRG1-Positive NSCLC and Pancreatic Cancer

January 16th 2025

Alison Schram, MD, details data from the eNRGy study that supported the FDA approval of zenocutuzumab in NRG1 fusion–positive NSCLC and pancreatic adenocarcinoma.

Nivolumab Plus Ipilimumab May Offer Efficacious Therapeutic Approach in Rare GU Cancers

January 15th 2025

Bradley McGregor, MD, discusses the findings from a phase 2 study of nivolumab plus ipilimumab in rare GU cancers.

Study Identifies How Ovarian Cancer Protects Itself, Paves Way for Improved Immunotherapy Approach

January 15th 2025

Eczema-linked protein helps cancer survive, suggesting potential for skin drug-based treatment.

Phase 3 RCC Data Reinforce Efficacy of Standard IO/TKI Doublets Across IMDC Risk Groups

January 15th 2025

Yousef Zakharia, MD, spotlights findings from 3 key trials informing the use of standard IO/TKI regimens in metastatic clear cell renal cell carcinoma.

Clinical, Molecular Factors Correlate With pCR for Durvalumab/Trastuzumab/Pertuzumab in Early HER2+ Breast Cancer

January 15th 2025

Polly Niravath, MD, discusses data from an analysis conducted in a study of durvalumab, trastuzumab, and pertuzumab in early HER2-positive breast cancer.

Tisotumab Vedotin Boosts Survival in Chinese Subpopulation With Previously Treated Cervical Cancer

January 15th 2025

Tisotumab vedotin led to improved survival vs chemotherapy in a Chinese subpopulation of previously treated cervical cancer enrolled in innovaTV 301.

FDA Approval Is Sought for TAR-200 in BCG-Unresponsive High-Risk NMIBC With CIS

January 15th 2025

An NDA has been submitted to the FDA seeking the approval of TAR-200 for BCG-unresponsive high-risk NMIBC with CIS, with or without papillary tumors.

NGS-Based xT CDx Test Is Now Commercially Available in United States for Solid Tumor Profiling

January 15th 2025

The xT CDx assay is now available nationwide in the United States for use in solid tumor profiling.