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.
CDK4/6 Inhibitor Shows Promise as Single Agent in HR+ Breast Cancer
July 6th 2016Maura Dickler, MD, discusses findings from the recent phase II study exploring abemaciclib as a single agent in patients with HR-positive breast cancer, along with an upcoming phase III trial looking at combination strategies.
EC Grants Brentuximab Vedotin New Indication for Hodgkin Lymphoma
July 6th 2016The European Commission has approved brentuximab vedotin (Adcetris) for use as a consolidation therapy following autologous stem cell transplantation in patients with CD30-positive Hodgkin lymphoma at risk of relapse or progression.
CMS Announces Practices Participating in OCM and Launch Date
June 30th 2016A year after announcing its intention to launch the Oncology Care Model alternative payment plan for oncology care, The Centers for Medicare & Medicaid Services said it has 196 practices enrolled across the United States and that the official start date is Friday, July 1.
Pazdur Named Head of New Oncology Center of Excellence
June 30th 2016Richard Pazdur, MD, has been named the acting director of the FDA's newly created Oncology Center of Excellence, which is aimed to expedite the development of novel combination products and support an integrated approach to oncology research.
EMA Approval Sought for Neratinib in HER2+ Breast Cancer
June 28th 2016A marketing authorization application has been submitted to the European Medicines Agency for neratinib as a potential extended adjuvant therapy for patients with HER2-positive early stage breast cancer following 12 months of trastuzumab.
CHMP Recommends Approval of Pembrolizumab for Lung Cancer
June 28th 2016The EMA's Committee for Medicinal Products for Human Use has granted a positive opinion for use of pembrolizumab (Keytruda) as a treatment for patients with locally advanced or metastatic PD-L1-positive non–small cell lung cancer.
FDA Grants Nivolumab Breakthrough Designation for Advanced Bladder Cancer
June 28th 2016The FDA has granted nivolumab (Opdivo) a breakthrough therapy designation for the treatment of patients with unresectable locally advanced or metastatic urothelial carcinoma after the failure of a platinum-containing regimen.
First-in-Human CRISPR Immunotherapy Would Target PD-1
June 24th 2016At a time when PD-1 inhibitors are dominating the immunotherapy field, a team of researchers is seeking to use groundbreaking CRISPR gene editing technology for the first time in human beings to create an engineered T-cell agent that would knock out the gene that controls the immune checkpoint’s activity.
OncLive Teams Up with European CanCer Organisation to Dispense Groundbreaking Oncology Content
June 23rd 2016OncLive, a leading provider of news, resources and information to oncology professionals, has entered into a collaborative agreement with the European CanCer Organisation (ECCO), the united voice of European cancer professionals, to deliver engaging oncological clinical and patient-focused content to audiences throughout the United States and Europe.