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.
HER2-Enriched Molecular Subgroup Highly Sensitive to Breast Cancer Regimens
November 24th 2015The primary analysis of the phase III CALGB 40601 trial found that pathologic complete response to dual HER2 blockade was not statistically higher than anti-HER2 monotherapy. However, there was a high level of intertumoral heterogeneity, and patients with the HER2-enriched subtype had a high pCR with both single and dual anti-HER2 therapy.
Diagnostic Testing Is a Wild West of Unknowns, Perils
November 23rd 2015The problem with FDA involvement in the regulation of molecular diagnostics testing is not only the esoteric scientific behind them but also the rapid-fire developments in the field that can make slow moving FDA determinations irrelevant by the time they become official.
Avelumab Receives Breakthrough Therapy Designation for Merkel Cell Carcinoma
November 18th 2015The FDA has granted a breakthrough therapy designation to avelumab as a potential treatment for patients with metastatic Merkel cell carcinoma following progression on at least one prior chemotherapy regimen.