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.

EMA Validates Marketing Authorization Application for Nirogacestat in Desmoid Tumors

February 29th 2024

The European Medicines Agency has validated a marketing authorization application seeking the approval of nirogacestat for patients with desmoid tumors.

Damian Green, MD, to Lead Transplantation and Cellular Therapy

February 29th 2024

The blood cancer expert comes to Sylvester Comprehensive Cancer Center after leading the discovery and testing of several immunotherapy approaches.

FDA Approval Highlights: OncLive’s February Recap

February 29th 2024

In case you missed it, below is a recap of all drugs that have been approved by the FDA in February 2024.

FDA Approves Label Expansion for Oral Ibrutinib Suspension in All Current Indications

February 28th 2024

The FDA has approved a label expansion for ibrutinib with an oral suspension formulation in all current indications.

Belzutifan Regimens Show Promise in RCC as Frontline IO/TKI Armamentarium Expands

February 28th 2024

Nikhil A. Gopal, MD, discusses the benefit of belzutifan in addition to effective immunotherapy-based regimens in advanced RCC.

Osimertinib Plus Chemo Adds Combination Strategy to Advanced EGFR+ NSCLC Armamentarium

February 28th 2024

Pasi A. Jänne, MD, PhD discusses the FDA approval of osimertinib plus chemotherapy for patients with EGFR-positive non–small cell lung cancer.

FDA Grants Orphan Drug Designation to LUT014 for EGFR Inhibitor–Induced Rash

February 28th 2024

The FDA granted an orphan drug designation to LUT014 for the treatment of EGFR inhibitor–induced acneiform rash.

Outsmarting Chemo-Resistant Ovarian Cancer

February 28th 2024

Northwestern Medicine scientists have discovered the Achilles heel of chemotherapy-resistant ovarian cancer—its hunger for cholesterol.

NCCN Lists Ropeginterferon Alfa-2B As Preferred First-Line Cytoreductive Therapy for Polycythemia Vera

February 28th 2024

The National Comprehensive Cancer Network recommends ropeginterferon alfa-2b as first-line cytoreductive therapy for polycythemia vera.

Brexu-Cel Delivers Prolonged OS Benefit in Relapsed/Refractory MCL

February 28th 2024

Andre H. Goy, MD, discusses how the ZUMA-18 trial data support the benefit of earlier-line use of brexucabtagene autoleucel in mantle cell lymphoma.

FDA Awards Fast Track Designation to 9MW2821 for Advanced ESCC

February 28th 2024

The FDA granted fast track designation to 9MW2821 for potential use in advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

Rusfertide More Than Triples Responses Vs Placebo in Phlebotomy-Dependent Polycythemia Vera

February 27th 2024

Rusfertide displayed activity in phlebotomy-dependent polycythemia vera.

Bezuclastinib Improves Mast Cell Burden, TSS Vs Placebo in Nonadvanced Systemic Mastocytosis

February 27th 2024

Bezuclastinib plus BSC improved mast cell burden and total symptom score vs placebo plus BSC in adult patients with nonadvanced systemic mastocytosis.

FDA Grants Breakthrough Therapy Designation to NVL-520 for Metastatic ROS1+ NSCLC

February 27th 2024

The FDA has granted breakthrough therapy designation to NVL-520 for pretreated, metastatic ROS1-positive non–small cell lung cancer.

FDA Accepts BLA for First-Line Tislelizumab Plus Chemotherapy in Gastric/GEJ Cancer

February 27th 2024

The biologics license application for first-line tislelizumab plus chemotherapy for gastric/gastroesophageal junction cancer has been accepted by the FDA.

FDA Grants Priority Review to sBLA of Epcoritamab in Relapsed/Refractory Follicular Lymphoma

February 27th 2024

The FDA has granted priority review to the sBLA of epcoritamab for relapsed/refractory follicular lymphoma.

Virginia Health Systems Partner as Part of New NIH Research Network Evaluating Emerging Cancer Screening Technologies

February 27th 2024

Three Virginia health systems together will serve as one of eight groups in the U.S. to conduct research for the Cancer Screening Research Network.

Discordant dMMR/IHC Status Correlates With Improved Treatment Outcomes in CRC and Endometrial Cancer

February 27th 2024

Patients with mismatch repair–deficient, immunohistochemistry-intact colorectal cancer or endometrial cancer benefit from immune checkpoint inhibitors.

Addition of Lifileucel to Advanced Melanoma Arsenal Marks Milestone for TIL Therapy in Solid Tumor Management

February 27th 2024

Daniel Olson, MD, discusses the significance of the FDA approval of lifileucel for patients with advanced melanoma.

TACE Plus Durvalumab and Bevacizumab Could Alter SOC in Embolization-Eligible, Unresectable HCC

February 26th 2024

Riccardo Lencioni, MD, discusses how TACE, durvalumab, and bevacizumab, could represent a new standard of care in embolization-eligible HCC.