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.
Genomic, Transcriptomic Profiling Lays Groundwork for Personalization in RCC
January 29th 2019RNA-based analyses of prospectively-collected tumor specimens from patients with metastatic renal cell carcinoma in the phase III COMPARZ trial revealed 4 molecular subgroups, of which a high angiogenesis expression and a low macrophage infiltrate were indicative of response to frontline TKI therapy.
Dana-Farber Researchers Win Grand Challenge Funding from Cancer Research UK
January 25th 2019Dana-Farber Cancer Institute researchers are Grand Challenge winners for a project that aims to discover how certain microbes inside the body lead to colorectal cancer and influence a patient’s response to treatment.
European Commission Approves Maintenance Rucaparib in Ovarian Cancer
January 25th 2019The European Commission has approved an expanded indication for single-agent rucaparib as a maintenance therapy in adult patients with platinum-sensitive, relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy, regardless of BRCA status.
BMS Withdraws Application for Nivolumab/Ipilimumab in TMB-High NSCLC
January 24th 2019Bristol-Myers Squibb has withdrawn its supplemental biologics license application for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for the frontline treatment of patients with advanced non–small cell lung cancer with tumor mutational burden ≥10 mutations per megabase.
Selinexor/Daratumumab Combo Shows Promise in Relapsed/Refractory Myeloma
January 22nd 2019Cristina Gasparetto, MD, discusses the combination of daratumumab, selinexor, and dexamethasone in patients with multiple myeloma who have previously received ≥3 lines of therapy, which include an immunomodulatory agent and a proteasome inhibitor.
FDA Approval Sought for Daratumumab/Rd for Frontline Transplant-Ineligible Myeloma
January 22nd 2019A supplemental Biologics License Application (sBLA) has been initiated with the FDA for daratumumab (Darzalex) for use in combination with lenalidomide (Revlimid) and dexamethasone (DRd) for the treatment of certain patients with multiple myeloma.