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.

NDA for Zipalertinib in Pretreated NSCLC With EGFR Exon 20 Insertion Mutations Is Submitted to the FDA

November 21st 2025

A rolling NDA submission for zipalertinib in NSCLC with EGFR exon 20 insertion mutations who received prior chemotherapy has been initiated.

FDA Accepts NDA for Zidesamtinib in ROS1+ Advanced NSCLC After a Prior TKI

November 21st 2025

Will the FDA approve zidesamtinib for ROS1-positive advanced non–small cell lung cancer after a prior TKI?

New Study Shows Lung Cancer Surveillance in the United States Misses Most Patients; Northwestern Medicine Researchers Urge Universal Age-Based Screening

November 21st 2025

Northwestern Medicine researchers discovered only 35% of patients would have qualified for lung cancer screening according to the U.S. Preventive Services Task Force (USPSTF) criteria.

CELMoDs Aim to Build on Established IMiDs in Multiple Myeloma Management

November 21st 2025

Joshua Richter, MD, discusses the exploration of CELMoDs in the treatment of patients with multiple myeloma.

The Essential But Often Complex Role of Numbers and Measurements in Oncology

November 20th 2025

Maurie Markman, MD, discusses the evolving role of measurements in cancer care.

Venetoclax-Enhanced RBAC Shows Promise in High-Risk Mantle Cell Lymphoma

November 20th 2025

Carlo Visco, MD, discusses phase 2 FIL_V-RBAC results showing venetoclax plus RBAC achieved a meaningful PFS and manageable toxicity in high-risk MCL.

FDA Clears Oncomine Dx Target Test as Companion Diagnostic for Sevabertinib in NSCLC

November 20th 2025

The FDA OKs the Oncomine Dx Target Test to identify patients with HER2 TKD–mutant NSCLC eligible for sevabertinib, enabling targeted treatment selection.

FDA Approves Osvyrti and Jubereq in High Fracture Risk Populations, Including in Breast and Prostate Cancer

November 20th 2025

Denosumab-desu (Osvyrti and Jubereq) received FDA approval in the same indications as reference denosumab (Prolia and Xgeva).

Moffitt Study Reveals Way to Spark Immune Hotspots That Attack Tumors

November 20th 2025

Investigators at Moffitt Cancer Center have developed a novel biomaterial-based system that induces the formation of tertiary lymphoid-like structures.

Mecbotamab Vedotin Shows Potential to Extend Survival in Treatment-Refractory Soft Tissue Sarcomas

November 20th 2025

Mecbotamab vedotin showed promising survival gains and manageable safety in treatment-refractory soft tissue sarcomas.

Targeting OXPHOS With Lixumistat Could Lessen Chemoresistance in Pancreatic Cancer

November 20th 2025

Shubham Pant, MD, MBBS, and Ryan W. Huey, MD, MS, discuss OXPHOS pathway inhibition in pancreatic cancer with lixumistat.

FDA Grants Accelerated Approval to Sevabertinib in HER2-Mutated Nonsquamous NSCLC

November 19th 2025

The FDA approved sevabertinib for previously treated, nonsquamous non–small cell lung cancer with HER2 TKD activating mutations.

FDA Grants Full Approval to Tarlatamab for Extensive-Stage Small Cell Lung Cancer

November 19th 2025

The FDA has granted traditional approval to tarlatamab-dlle (Imdelltra) for the treatment of select patients with ES-SCLC.

Modified Daratumumab-Based Quadruplet Shows Feasibility in Older Multiple Myeloma

November 19th 2025

Andrew Yee, MD, discusses data for a modified four-drug regimen studied in older patients with newly diagnosed multiple myeloma.

FDA Approves Daratumumab and Hyaluronidase-fihj in Newly Diagnosed Light Chain Amyloidosis

November 19th 2025

The FDA has granted traditional approval to daratumumab and hyaluronidase-fihj with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain amyloidosis.

European Commission Approves Subcutaneous Mosunetuzumab in R/R Follicular Lymphoma

November 19th 2025

The European Commission has approved subcutaneous mosunetuzumab for relapsed/refractory follicular lymphoma.

Adjuvant Cemiplimab Cleared in EU for CSCC With High Recurrence Risk After Surgery and Radiation

November 19th 2025

Cemiplimab wins EU approval after C-POST shows DFS gains for high-risk CSCC, marking the first effective adjuvant immunotherapy option.

FDA Approves Selumetinib for Adult NF1-Associated Plexiform Neurofibromas

November 19th 2025

The FDA approved selumetinib for the treatment of adults with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.

Shaping the Future of Care for Neuroendocrine Tumors

November 19th 2025

Fox Chase Cancer Center’s Namrata ‘Neena’ Vijayvergia, MD, an expert in gastrointestinal cancers and rare NETs, was recently recognized by two NET advocacy groups for her contributions to the field.

Beyond the Biopsy: A New Blood Test Is Redefining the Fight Against Relapsed AML

November 19th 2025

Liquid biopsy offers a revolutionary approach for detecting relapse in AML patients post-stem cell transplant, potentially enhancing early intervention.