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.
FDA Grants Nivolumab Breakthrough Designation for Head and Neck Cancer
April 25th 2016The FDA has granted a breakthrough therapy designation to nivolumab as a single-agent treatment for patients with recurrent or metastatic squamous cell carcinoma of the head and neck following a platinum-based therapy.
Analysis of Real-World Data for Next-Generation Antiandrogen Therapies
April 25th 2016Real-world data obtained from large retrospective studies can also deliver useful insights into the clinical challenges associated with newer therapies in prostate cancer, such as medication adherence and cognitive adverse events.
Optimal Sequencing Explored for Enzalutamide and Abiraterone in mCRPC
April 22nd 2016Although abiraterone acetate (Zytiga) and enzalutamide (Xtandi) have demonstrated improved survival outcomes, the optimal sequencing of these therapies has not been established, and most patients exhibit some degree of cross-resistance.
Frontline Palbociclib Extends PFS in Phase III Breast Cancer Study
April 19th 2016The phase III PALOMA-2 trial has shown a significant improvement in progression-free survival for the frontline combination of palbociclib and letrozole compared letrozole alone for patients with ER-positive, HER2-negative advanced or metastatic breast cancer.
Addressing Therapeutic Challenges for Geriatric Patients With mCRPC
April 15th 2016Clinicians must consider and evaluate the unique characteristics and treatment options for older men with prostate cancer, who are more likely to be diagnosed with advanced disease, and tend to have higher mortality rates and poorer prognosis.
ODAC Rejects Rociletinib in Lung Cancer
April 12th 2016The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12-1 against the accelerated approval of rociletinib as a treatment for patients with metastatic EGFR T790M–mutated non–small cell lung cancer (NSCLC) who have previously received an EGFR-targeted therapy.
Expert Discusses Microsatellite Instability, Immunotherapy in CRC
April 11th 2016Zsofia K. Stadler, MD, provides extensive insight on microsatellite instability in colorectal cancer, the biology of and screening for MSI tumors, and the potential impact immunotherapy could have on the treatment paradigm.
Pancreatic Cancer Survival Rates Lower in Real World Than Clinical Trials
April 8th 2016Patients with pancreatic adenocarcinoma enrolled on clinical trials have “profoundly improved survival†compared with patients in the general population, suggesting that oncologists who use trial data to prognosticate may be missing the mark.