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 Extends Review Period for Frontline Nivolumab/Ipilimumab in TMB-High NSCLC
October 22nd 2018The FDA has added 3 months to the review period for the combination of nivolumab plus low-dose ipilimumab for the frontline treatment of patients with advanced non–small cell lung cancer with tumor mutational burden ≥10 mutations per megabase.
Gomella Gives Update on Nonmetastatic CRPC Advances
October 19th 2018Leonard G. Gomella, MD, professor, chair, Department of Urology, director, Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital, discusses the shifting landscape of nonmetastastic CRPC, along with other developments across the prostate cancer paradigm.
FDA Grants Priority Review to Ibrutinib Plus Obinutuzumab in Frontline CLL
October 17th 2018The FDA has granted a priority designation to a supplemental new drug application for ibrutinib for use in combination with obinutuzumab for the frontline treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Adjuvant T-DM1 Improves iDFS in Phase III HER2+ Breast Cancer Trial
October 15th 2018Ado-trastuzumab emtansine (T-DM1; Kadcyla) was found to significantly reduce the risk of disease recurrence or death compared with trastuzumab (Herceptin) as an adjuvant treatment in patients with HER2-positive early breast cancer who have residual disease following neoadjuvant therapy.
FDA Grants LOXO-292 Breakthrough Designation for RET Fusion-Positive Thyroid Cancer
October 15th 2018The FDA has granted LOXO-292 a breakthrough therapy designation for the treatment of patients with advanced RET fusion–positive thyroid cancer who require systemic therapy, have progressed on prior treatment, and have no other acceptable alternative treatment options.