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 Nivolumab/Ipilimumab Improves OS in PD-L1+ NSCLC
July 25th 2019The combination of nivolumab (Opdivo) and low-dose ipilimumab (Yervoy) was superior in overall survival compared with chemotherapy for the first-line treatment of patients with non–small cell lung cancer whose tumors express PD-L1 ≥1%, meeting the co-primary endpoint of part 1a of the phase III CheckMate-227 trial.
UT Southwestern Researchers Find Evidence a Cancer Drug May Be Extended to Many More Patients
July 24th 2019A new molecular mechanism discovered by UT Southwestern researchers indicates that drugs currently used to treat less than 10 percent of breast cancer patients could have broader effectiveness in treating all cancers where the drugs are used, including ovarian and prostate cancers.
Multidisciplinary Effort Key to Successful Lung Cancer Screening Programs
July 24th 2019Mollie Meek, MD, highlights key lung cancer screening trials, offered insight into how to successfully implement an effective program, and stressed that collaboration is critical in order to provide the best patient care.
FDA Approves Rituximab Biosimilar for CD20+ B-Cell Non-Hodgkin Lymphoma and CLL
July 23rd 2019The FDA has approved PF-05280586, a biosimilar for rituximab, for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma as a single agent or in combination with chemotherapy, or for patients with CD20-positive chronic lymphocytic leukemia in combination with chemotherapy.
ctDNA Monitoring Carries Clinical Validity in Advanced BRAF-Mutant Melanoma
July 23rd 2019David Polsky, MD, PhD, discusses findings from an analysis in patients with BRAF-mutant, unresectable, metastatic melanoma, as well as the next steps for validating these findings and potentially using circulating tumor DNA to help inform treatment decisions.
FDA Grants Breakthrough Designation to Frontline Pembrolizumab/Lenvatinib for HCC
July 23rd 2019The FDA has granted a breakthrough therapy designation to the combination of pembrolizumab and lenvatinib for the first-line treatment of patients with advanced unresectable hepatocellular carcinoma that is not amenable to locoregional therapy.
FDA Updates Durvalumab NSCLC Label to Include OS Data
July 22nd 2019The FDA has updated the label for durvalumab for patients with unresectable, stage III non–small cell lung cancer whose disease has not progressed following concurrent platinum-based chemoradiation to include overall survival data from the phase III PACIFIC trial.
Key Trials Showcase the Utility of Neratinib in HER2+ Breast Cancer
July 19th 2019Michel Velez, MD, provides perspective on the clinical experience with neratinib in patients with early-stage HER2-positive breast cancer as well as promising data that may lead to an indication in the metastatic setting.
Regorafenib/Nivolumab Combo to Be Explored in Phase III MSS CRC Trial
July 18th 2019The combination of regorafenib and nivolumab will be compared with regorafenib alone in a phase III trial of patients with microsatellite stable colorectal cancer, following encouraging phase Ib findings of the REGONIVO study.
Neratinib Approved in Canada for Early-Stage HER2+ Breast Cancer
July 17th 2019Health Canada has approved neratinib (Nerlynx) for the extended adjuvant treatment of patients with early-stage, hormone receptor–positive, HER2-overexpressed/amplified breast cancer within 1 year after completing trastuzumab (Herceptin)-based adjuvant therapy.