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.

Frontline Pembrolizumab Plus Trastuzumab/Chemo Improves PFS in HER2+ Advanced Gastric or GEJ Adenocarcinoma

June 16th 2023

The addition of pembrolizumab to trastuzumab and chemotherapy improved progression-free survival over trastuzumab and chemotherapy alone when used as a frontline regimen in patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

European Medicines Agency Validates MAA for Fruquintinib in Pretreated mCRC

June 16th 2023

The European Medicines Agency has validated and accepted a marketing authorization application for priority review for fruquintinib for the treatment of adult patients with pretreated metastatic colorectal cancer.

Pacritinib Provides Spleen, Symptom Reduction Regardless of Blood Counts, Association Between SVR and OS in Myelofibrosis

June 16th 2023

Treatment with the JAK2 inhibitor pacritinib demonstrated comparable improvements in spleen and symptom response regardless of baseline platelet counts and hemoglobin levels, according to findings from the pivotal phase 3 PERSIST-1 and PERSIST-2 trials.

The Impact of Genomic Profiling on Cancer Treatment: Insights from FCS President and Managing Physician

June 16th 2023

Florida Cancer Specialists & Research Institute President & Managing Physician Lucio N. Gordan, MD, will join an expert panel of precision medicine leaders in Chicago this weekend to discuss the impact of genomic profiling.

FDA Extends Review Period for Momelotinib NDA in Myelofibrosis

June 16th 2023

The FDA has extended the review period for the new drug application seeking the approval of momelotinib as a potential therapeutic option in patients with myelofibrosis.

Building Upon Scaffolds

June 16th 2023

Cancer care is changing rapidly, and understanding and incorporating new practices is challenging both for practicing oncologists and oncology trainees.

Phase 1 Trial Set to Explore Efficacy and Safety of KB-0742 in Solid Tumors

June 16th 2023

Brian Van Tine, MD, PhD, discusses key considerations for understanding the biology of MYC, the rationale for the phase 1 study of KB-0742 in MYC-amplified or -overexpressed relapsed or refractory solid tumors, and patient characteristics that may signal their eligibility for participation in this trial.

FDA Approves Glofitamab-gxbm for Relapsed/Refractory DLBCL

June 16th 2023

The FDA has approved glofitamab-gxbm (Columvi) for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy.

Duvelisib Demonstrates Higher Activity in Angioimmunoblastic Peripheral T-Cell Lymphoma

June 15th 2023

Treatment with duvelisib led to a high response rate in patients with peripheral T-cell lymphoma, with activity favoring patients with PTCL not otherwise specified and angioimmunoblastic T-cell lymphoma.

Gedatolisib Triplet Shows Early Efficacy in Previously Untreated ER+/HER2– Breast Cancer

June 15th 2023

The addition of gedatolisib to palbociclib and letrozole produced durable responses with comparable safety to that observed with palbociclib and letrozole alone in treatment-naïve patients with estrogen receptor-positive, HER2-negative advanced breast cancer.

Ziftomenib Displays Early-Phase Efficacy in Relapsed or Refractory AML

June 15th 2023

Investigators of the phase 1/2 KOMET-001 trial are seeking to address unmet needs in AML with the investigational menin inhibitor ziftomenib.

Toripalimab Plus Chemo Elicits Significant OS Improvement in Recurrent or Metastatic Nasopharyngeal Carcinoma

June 15th 2023

First-line treatment with toripalimab in combination with gemcitabine and cisplatin resulted in a statistically significant and clinically meaningful improvement in overall survival and progression-free survival vs placebo plus chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma.

Fox Chase Cancer Center Welcomes Dr. David Loren

June 15th 2023

Fox Chase Cancer Center is pleased to announce the hiring of David Loren, MD, FASGE, as professor of medicine and chief of the Section of Gastroenterology in the Department of Medicine.

Infigratinib Receives Breakthrough Therapy Designation in China for Gastric Cancer

June 15th 2023

China’s National Medical Products Administration has granted a breakthrough therapy designation to infigratinib for the treatment of patients with gastric cancer.

Persistence Is Key to Success

June 15th 2023

Vinay Edlukudige Keshava, MD, shares the story of his fellowship and provides advice on how to best transition to the next step in an oncologic career.

Real-World Analysis Supports Use of Brexu-Cel in Relapsed/Refractory MCL

June 15th 2023

The real-world efficacy and safety of brexucabtagene autoleucel were similar to the outcomes seen in the phase 2 ZUMA-2 trial, regardless of patients’ treatment history, according to results from a real-world subgroup analysis of patients with relapsed/refractory mantle cell lymphoma.

FDA Accepts sNDA for Frontline NALIRIFOX in Metastatic Pancreatic Ductal Adenocarcinoma

June 14th 2023

The FDA has accepted a supplemental new drug application seeking approval of the NALIRIFOX regimen comprised of irinotecan liposome injection plus 5-fluorouracil, leucovorin, and oxaliplatin as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma.

FDA Approves New Drug Application for Oncology Injectable Pemrydi RTU

June 14th 2023

The FDA has approved a 505(b)(2) new drug application for Pemrydi RTU, the first and only ready-to-use presentation of pemetrexed or injection that does not require reconstitution, dilution, or refrigeration

Neoadjuvant Zanidatamab Shows Early Efficacy, Tolerability in Early-Stage, Node-Negative, HER2+ Breast Cancer

June 14th 2023

Neoadjuvant zanidatamab monotherapy successfully reduced the incidence of residual disease and was well tolerated in treatment-naïve women with node negative, stage I HER2-positive breast cancer, potentially allowing patients to achieve pathologic complete responses in the absence of chemotherapy.

Frontline Pembrolizumab Plus Lenvatinib Has Antitumor Activity in Non–clear Cell RCC

June 14th 2023

The first-line combination of lenvatinib and pembrolizumab elicited durable responses with a manageable safety profile in patients with non–clear cell renal cell carcinoma, according to findings from the phase 2 KEYNOTE-B61 trial.