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 Accepts Marketing Application for Odronextamab in R/R DLBCL or Follicular Lymphoma

August 17th 2023

The European Medicines Agency has accepted a marketing authorization application seeking the approval of odronextamab for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma who have progressed after at least 2 prior systemic therapies.

FDA Grants Orphan Drug Designation to NXP800 for Cholangiocarcinoma

August 17th 2023

The FDA has granted an orphan drug designation to NXP800 for the treatment of patients with cholangiocarcinoma.

On-Pathway Regimens Are Associated With Significant Cost Savings for Treatment of Solid Tumors

August 17th 2023

Findings from a cross-institutional study suggest that on-pathway regimens led to significant cost savings for patients with cancer, despite the rate of hospitalizations and immune-related adverse events being similar between on-pathway and off-pathway regimens.

Pembrolizumab Elicits Long-Term Survival Benefit in Advanced Melanoma

August 17th 2023

Pembrolizumab demonstrated long-term survival benefit compared with ipilimumab in patients with unresectable stage III/IV melanoma who received up to 1 prior systemic therapy.

Randall Discusses the Importance of Identifying and Managing Chondroblastoma in Clinical Practice

August 16th 2023

R. Lor Randall, MD, FACS, explains the difference between noncancerous chondroblastoma and other bone neoplasms, details the typical diagnosis and treatment of this rare condition, and emphasizes the importance of pediatric and medical oncologists being able to identify it in clinic.

FDA Grants Breakthrough Device Designation to HLA-LOH Companion Diagnostic Test

August 16th 2023

The FDA has granted a breakthrough device designation to HLA-LOH as a companion diagnostic test, according to an announcement from Tempus.

NK T-Cell Agonist Under Investigation in Combination With Pembrolizumab in Melanoma and NSCLC

August 16th 2023

The natural killer T-cell agonist IMM60 may overcome resistance to PD-1 inhibitors when combined with immunotherapy in patients with melanoma and non–small cell lung cancer.

Repotrectinib Sustains ORR, Safety in Locally Advanced or Metastatic ROS1+ NSCLC

August 16th 2023

Treatment with repotrectinib continued to produce high and durable responses with a manageable safety profile in patients with ROS1-positive locally advanced or metastatic non–small cell lung cancer who were naïve to a TKI or previously treated with 1 TKI and no chemotherapy.

Tucatinib/Letrozole/Palbociclib Combination Demonstrates Meaningful Efficacy in HR+/HER2+ mBC

August 16th 2023

Treatment with the all-oral triplet of tucatinib, letrozole, and palbociclib yielded clinically meaningful efficacy results and had an acceptable safety profile in patients with hormone receptor–positive, HER2-positive metastatic breast cancer.

MB-106 Shows Continued Activity in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

August 16th 2023

MB-106, a first-in-class, CD20-targeted autologous CAR T-cell therapy, led to durable clinical responses with low-grade cytokine release syndrome in patients with indolent lymphoma.

University of Texas System Regents Announce Plans to Build UT Medical Center On Site of Erwin Center

August 16th 2023

The nation’s top-ranked UT MD Anderson Cancer Center and flagship UT Austin to build new hospitals as part of project.

Vemurafenib Plus Cobimetinib Demonstrates Near 100% Response Rate in Papillary Craniopharyngiomas

August 16th 2023

The combination of vemurafenib and cobimetinib led to a 94% partial response rate or better in 16 patients with newly diagnosed BRAF-mutated papillary craniopharyngiomas.

Tucatinib Plus T-DM1 Improves PFS in Previously Treated HER2+ Metastatic Breast Cancer

August 16th 2023

The combination of tucatinib and ado-trastuzumab emtansine elicited an improvement in progression-free survival compared with placebo plus T-DM1 in patients with HER2-positive metastatic breast cancer who received previous treatment with a taxane and trastuzumab in any setting.

Addition of Navitoclax to Dabrafenib/Trametinib Aims to Improve Efficacy of Targeted Therapy in BRAF+ Metastatic Melanoma

August 15th 2023

Zeynep Eroglu, MD, explains the rationale for adding navitoclax to dabrafenib plus trametinib in the treatment of patients with BRAF V600–mutant metastatic melanoma, highlights the methodologies and results of the CTEP-P9466 trial, and describes the implications of this research for this patient population.

Oral ATO/ATRA/Ascorbic Acid Regimen Delivers Durable Responses in APL

August 15th 2023

Harry Gill, MD, discusses the importance of offering patients with APL an entirely oral treatment regimen, key efficacy findings from this trial, and the tolerability of this regimen.

FDA Grants Priority Review to Ivosidenib for IDH1+ Relapsed/Refractory MDS

August 15th 2023

The FDA has granted priority review to the supplemental new drug application seeking the approval of ivosidenib for the treatment of patients with IDH1-mutated, relapsed/refractory myelodysplastic syndrome.

Copper 64 PSMA I&T Meets Coprimary End Points of SOLAR Trial in Metastatic Prostate Cancer

August 15th 2023

Use of Copper 64 PSMA I&T for PET/CT imaging met the threshold for significance regarding region-level correct localization rate and patient-level correct detection rate in patients with histologically confirmed metastatic prostate cancer, meeting the coprimary end points of the phase 2 SOLAR trial.

Mother & Daughter: How Cancer Shaped the Career Path of the Office for Community Outreach & Engagement’s Program Director Francine Walton, MPH

August 15th 2023

Francine Walton, MPH, shares how her mother has shaped her perspective on the cancer journey, including the importance of hope and resilience in the face of adversity.

FDA Lifts Clinical Hold on BCMA-Directed Modified CAR T-Cell Therapy in Multiple Myeloma

August 15th 2023

The FDA has lifted the partial clinical hold placed on the clinical program evaluating the investigational new drug, CART-ddBCMA, in the treatment of patients with relapsed/refractory multiple myeloma.

Updates on Imaging-Based Pancreatic Cancer Surveillance for Individuals With Increased Genetic and Familial Risk

August 15th 2023

Recent years have brought tremendous progress in demonstrating that there is hope for improving mortality from pancreatic ductal adenocarcinoma through early detection.