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 Pomalidomide Breakthrough Designation in Kaposi Sarcoma
May 13th 2019The FDA has granted a breakthrough therapy designation to pomalidomide for use as a treatment for patients with HIV-positive Kaposi sarcoma who have received prior chemotherapy, as well as patients with HIV-negative Kaposi sarcoma.
Nivolumab/RT Combo Misses OS Endpoint in Newly Diagnosed Glioblastoma Trial
May 10th 2019The combination of nivolumab plus radiation therapy compared with temozolomide did not improve overall survival in patients with newly diagnosed O6-methylguanine-DNA methyltransferase-unmethylated glioblastoma multiforme, missing the coprimary endpoint of the phase III CheckMate-498 trial.
[Fam-] Trastuzumab Deruxtecan Elicits Responses in Advanced HER2+ Breast Cancer
May 8th 2019The antibody-drug conjugate [fam-] trastuzumab deruxtecan (DS-8201) demonstrated encouraging responses in patients with unresectable and/or metastatic HER2-positive breast cancer that has been previously treated with ado-trastuzumab emtansine, according to topline findings from the phase II DESTINY-BreastO1 study.
Vaccine Shows Signs of Stimulatory Effects in Early-Stage CRC
May 8th 2019A vaccine targeting GUCY2C, a commonly overexpressed protein in patients with early-stage colorectal cancer, induced antibody and T-cell responses toward the specified target and demonstrated an acceptable safety profile in this patient population