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 Ribociclib Breakthrough Designation for HR+/HER2- Premenopausal Breast Cancer
January 3rd 2018The FDA has granted ribociclib a breakthrough therapy designation for use in combination with tamoxifen or an aromatase inhibitor as frontline treatment for pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.
FDA Grants Priority Review to Frontline Brentuximab Vedotin for Hodgkin Lymphoma
January 2nd 2018The FDA has granted a priority review to a supplemental biologics license application for brentuximab vedotin (Adcetris) in combination with Adriamycin, vinblastine, and dacarbazine (AVD) as a frontline treatment for advanced classical Hodgkin lymphoma.
Dual HER2 Blockade Superior for PFS in HER2+/HR+ Metastatic Breast Cancer
December 29th 2017The combination of lapatinib, trastuzumab, and an aromatase inhibitor (AI) reduced the risk for death or progression by 38% in women with HER2+/HR+ metastatic breast cancer compared with those treated with a targeted agent plus AI.
FDA Updates Nilotinib CML Label With Discontinuation Provision
December 23rd 2017The FDA has updated the label for nilotinib with a provision stipulating that patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase who have received the BCR-ABL tyrosine kinase inhibitor for at least 3 years and have achieved specific predetermined criteria may be eligible to stop treatment.
Rituximab/Lenalidomide Regimen Misses Endpoint in Phase III Follicular Lymphoma Study
December 22nd 2017The combination of rituximab and lenalidomide followed by maintenance therapy with the same regimen did not improve response nor progression-free survival compared with rituximab and chemotherapy with rituximab maintenance for patients with previously untreated follicular lymphoma.