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 Pembrolizumab Priority Review for Merkel Cell Carcinoma
September 4th 2018The FDA has granted a priority review to a supplemental biologics license application for pembrolizumab for the treatment of pediatric and adult patients with recurrent locally advanced or metastatic Merkel cell carcinoma.
Daratumumab/VMP Combo Approved in EU for Frontline Myeloma
August 31st 2018The European Commission has approved daratumumab for use in combination with bortezomib, melphalan, and prednisone (VMP) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
FDA Accepts Application for Dasatinib for Pediatric Ph+ ALL
August 30th 2018The FDA has accepted a supplemental biologics license application for dasatinib for use in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.
Blinatumomab Approved in Europe for Pediatric ALL
August 29th 2018The European Commission has approved blinatumomab for the treatment of pediatric patients with Philadelphia chromosome–negative, CD19-positive B-cell precursor acute lymphoblastic leukemia that is refractory or in relapse after receiving at least 2 prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.