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 Schedules ODAC Meetings for Pexidartinib in TGCT and Quizartinib in AML
April 19th 2019The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for May 14, 2019, to discuss a new drug application for pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor.
Gomella Calls for Increased Genetic Testing in Prostate Cancer
April 18th 2019Leonard G. Gomella, MD, underscores the need for genetic testing in prostate cancer, sheds light on important biomarkers in the space, and explains how these tests are helping oncologists facilitate a precision medicine approach.
Clinical Factors in MCL Successful in Guiding Watch-and-Wait Strategy
April 18th 2019Although biological criteria carry prognostic value in mantle cell lymphoma, initial observation based solely on clinical criteria was found to be an effective management strategy that did not compromise patient outcomes.
FDA Expands Approval of PD-L1 IHC 22C3 pharmDX Assay in NSCLC
April 17th 2019The FDA has expanded the approval of the PD-L1 IHC 22C3 pharmDX assay, allowing the test to be used as a companion diagnostic to identify more patients with stage III or metastatic non–small cell lung cancer who can undergo first-line treatment with pembrolizumab (Keytruda).
Personalized Medicine Progressing in Premenopausal Breast Cancer
April 17th 2019Joyce A. O’Shaughnessy, MD, discusses the clinical implications of the TEXT and SOFT trials for women with premenopausal HR-positive, HER2-negative breast cancer, as well as unanswered questions that remain with adjuvant endocrine therapy.
Daratumumab Elicits Low Responses in Relapsed/Refractory Non-Hodgkin Lymphoma
April 17th 2019Daratumumab was associated with low overall response rates in patients with relapsed/refractory diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma, missing the primary endpoint of a phase II trial published in Clinical Lymphoma, Myeloma & Leukemia.1