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.

Luspatercept Receives Positive EU CHMP Opinion for Treatment of Anemia in Lower-Risk MDS

February 23rd 2024

Luspatercept has been recommended for approval by the EMA for patients with transfusion-dependent anemia and lower-risk myelodysplastic syndromes.

CHMP Recommends Approval of Cilta-Cel for Early Relapsed/Refractory Multiple Myeloma

February 23rd 2024

The Committee for Medicinal Products for Human Use has recommended the approval of cilta-cel for earlier-line relapsed/refractory multiple myeloma.

Acalabrutinib/Axi-Cel Generates Preliminary Responses in Relapsed/Refractory B-Cell Lymphoma

February 23rd 2024

Early data seen with acalabrutinib plus axi-cel indicate the combination’s feasibility as bridging therapy in relapsed/refractory B-cell lymphoma.

Director of Oncology Services Northern Region Named to New Jersey’s Only NCI-Designated Comprehensive Cancer Center

February 22nd 2024

George Raptis, MD, MBA, begins role at Rutgers Cancer Institute of New Jersey and RWJBarnabas Health.

IO-202 Receives FDA Orphan Drug Designation for CMML

February 22nd 2024

The FDA has granted IO-202 an orphan drug designation for patients with chronic myelomonocytic leukemia.

CNS Remission Achieved With Brexu-Cel in Relapsed/Refractory B-ALL

February 22nd 2024

Brexu-cel showed efficacy in eliciting both CNS and systemic responses in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

Swissmedic Accepts Marketing Authorization Application for Piflufolastat (18F) for Prostate Cancer

February 22nd 2024

Swissmedic has accepted for review a marketing authorization application seeking the approval of Piflufolastat (18F) for prostate cancer.

Liso-Cel Proves Active Across High-Risk MCL Subgroups

February 22nd 2024

Liso-cel may be an effective treatment option for patients with relapsed/refractory mantle cell lymphoma and high-risk features.

Increased Understanding of CLL Tumor Biology Unlocks Targeted CAR T-Cell Approaches

February 22nd 2024

Jan Joseph Melenhorst, PhD, emphasizes how research investigating chronic lymphocytic leukemia biology may result in more targeted CAR T-cell products.

Bridging the Gap: Geriatric Assessment vs Routine Provider Evaluation in Gastroesophageal Cancer Care

February 21st 2024

Efrat Dotan, MD, discusses routine provider assessment vs the utility of geriatric assessment in geriatric patients with gastroesophageal disease.

FDA Grants Orphan Drug Designation to Ocifisertib for Acute Myeloid Leukemia

February 21st 2024

The FDA granted an orphan drug designation to ocifisertib for use as a potential therapeutic option in patients with acute myeloid leukemia.

Early Efficacy With Fedratinib in MDS/MPN and CNL Warrants Its Continued Evaluation

February 21st 2024

David A. Sallman, MD, discusses the potential use of fedratinib to manage symptomatic myelodysplastic syndrome/myeloproliferative neoplasms.

Currently Enrolling Trial Examines Innovative Approach in Inflammatory Breast Cancer

February 21st 2024

The S1706 study is currently enrolling patients with inflammatory breast cancer to determine if adding a PARP inhibitor to radiation therapy is effective.

New Digital Tool Aims to Improve Treatment Plans for Pediatric Cancer Patients

February 21st 2024

Jonathan Constance, PhD, and his team have created a digital pharmacology platform for assessing drug dynamics directly among children with cancer.

FDA Grants Priority Review to Linvoseltamab for Relapsed/Refractory Multiple Myeloma

February 21st 2024

A biologics license application for linvoseltamab in relapsed/refractory multiple myeloma has been accepted for priority review by the FDA.

Liso-Cel Maintains Longer-Term Responses in Pretreated Relapsed/Refractory CLL/SLL

February 21st 2024

Tatyana Feldman, MD, highlights updated data for liso-cel in relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.

FDA Grants Fast Track Status to IMM-1-104 for Pancreatic Cancer

February 21st 2024

IMM-1-104 received FDA fast track designation for use in patients with pancreatic ductal adenocarcinoma who have progressed on 1 line of treatment.

FDA Approves Bi-weekly Teclistamab Dosing for Relapsed/Refractory Multiple Myeloma

February 20th 2024

The FDA has approved a supplemental Biologics License Application for teclistamab-cqyv (Tecvayli) at a reduced dose of 1.5 mg/kg every 2 weeks in patients with relapsed/refractory multiple myeloma who have achieved and maintained a complete response or greater for at least 6 months.

FDA and EMA Accept Regulatory Submissions for Vorasidenib for IDH-Mutant Diffuse Glioma

February 20th 2024

Vorasidenib has been granted regulatory submission acceptance by the FDA and EMA for IDH-mutant diffuse glioma.

International Childhood Cancer Day Shines a Spotlight on Challenges in Pediatric Oncology

February 20th 2024

Burton Eliot Appel, MD, discusses the importance of recognizing Childhood Cancer Day in pediatric patients with cancer.