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 Assays Advance Personalized Care in Early-Stage Breast Cancer
April 16th 2019Mariana Chavez Mac Gregor, MD, MSc, discusses the optimal applications of these assays in patients with early-stage, HR-positive/HER2-negative breast cancer and shed light on the overall outlook of personalized medicine in this setting.
Olaparib/Neratinib Combo Highly Synergistic in HER2+ Uterine Serous Carcinoma
April 15th 2019The combination of the PARP inhibitor olaparib (Lynparza) and the pan-HER TKI neratinib (Nerlynx) proved to be highly synergistic and demonstrated significant activity in preclinical models of HER2-positive uterine serous carcinoma.
FDA Lowers Pembrolizumab PD-L1 Cutoff in NSCLC, Expands Approval to Stage III
April 12th 2019The FDA has expanded the approval for pembrolizumab monotherapy for the frontline treatment of patients with stage III non–small cell lung cancer, who are ineligible for surgery or definitive chemoradiation, or metastatic NSCLC, with a PD-L1 expression (tumor proportion score) level of ≥1% and do not harbor EGFR or ALK aberrations.
Bevacizumab/Erlotinib Adds Another Option to Frontline EGFR+ NSCLC
April 10th 2019Findings from the phase III NEJ026 study, presented at the 2018 ASCO Annual Meeting and now published in Lancet Oncology, showed that adding bevacizumab to erlotinib significantly improved progression-free survival versus erlotinib alone in patients with EGFR-positive, advanced nonsquamous non–small cell lung cancer.
Lenalidomide/Rituximab Data Published as FDA Weighs Non-Hodgkin Lymphoma Approval
April 9th 2019The R2 regimen of lenalidomide plus rituximab significantly reduced the risk of disease progression or death compared with rituximab alone in patients with relapsed/refractory indolent non-Hodgkin lymphoma, according to results from the pivotal phase III AUGMENT trial.
ACP Releases Breast Cancer Screening Guidance Statements for Asymptomatic, Average-Risk Women
April 9th 2019For women at average risk for breast cancer who are between the ages of 40 and 49 years, clinicians should have a personalized approach on whether their patients should be screened with mammography prior to the age of 50.
Frontline Approaches Fine-Tuned in Newly Diagnosed Ovarian Cancer
April 6th 2019Paul Sabbatini, MD, clarifies where the field stands regarding the use of bevacizumab, intraperitoneal therapy, and a 3-week dosing schedule of chemotherapy versus a weekly dose-dense regimen in the frontline setting of newly diagnosed ovarian cancer.
Sandoz Resubmits Application for Pegfilgrastim Biosimilar
April 5th 2019A biologics license application has been resubmitted to the FDA for the pegfilgrastim biosimilar LA-EP2006 to decrease the incidence of infection from febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer therapy.
FDA Approval Sought for Luspatercept for Anemias
April 5th 2019A supplemental biologics license application has been submitted to the FDA for luspatercept for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndrome–associated anemia with ring sideroblasts who require red blood cell transfusions, and also for adult patients with beta-thalassemia–associated anemia who require such transfusions.