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 Approves Abiraterone for High-Risk Prostate Cancer
February 8th 2018The FDA has approved abiraterone acetate in combination with prednisone and androgen deprivation therapy for high-risk patients with metastatic hormone-naïve prostate cancer or newly-diagnosed metastatic hormone-sensitive prostate cancer.
FDA Approval Sought for Duvelisib in CLL, Follicular Lymphoma
February 7th 2018A new drug application has been submitted to the FDA for duvelisib for a full approval for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and an accelerated approval in relapsed/refractory follicular lymphoma.
Pomalidomide Triplet Improves PFS in Relapsed/Refractory Myeloma
February 7th 2018Adding pomalidomide to the combination of bortezomib and low-dose dexamethasone led to a significant improvement in progression-free survival in patients with relapsed/refractory myeloma with prior exposure to lenalidomide.
Neoadjuvant Palbociclib/Pertuzumab Regimen Active in ER/HER2-Positive Breast Cancer
February 2nd 2018The neoadjuvant combination of palbociclib (Ibrance), pertuzumab (Perjeta), fulvestrant (Faslodex), and trastuzumab (Herceptin), cut expression of Ki67 and induced an overall clinical response of 29% in women with ER-positive/HER2-positive breast cancer.