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 Adds PD-L1 Expression to Frontline Pembrolizumab, Atezolizumab Urothelial Carcinoma Labels
June 21st 2018The FDA has incorporated PD-L1 status into the labels for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for existing frontline approvals for platinum-ineligible patients with urothelial carcinoma.
Blinatumomab Granted Full EU Approval for B-cell Precursor ALL
June 19th 2018The European Commission has granted blinatumomab full marketing authorization for the treatment of adult patients with Philadelphia chromosome-negative relapsed/refractory B-cell precursor acute lymphoblastic leukemia, according to Amgen, the developer of the anti-CD19 immunotherapy.
Expert Stresses Importance of End-of-Life Care in Pediatric Oncology
June 14th 2018Justin N. Baker, MD, discusses the benefits of a holistic approach to end-of-life care in pediatric oncology, as well as the importance of teaching palliative care to the next generation of oncologists and hematologists.
FDA Approves Pembrolizumab for Relapsed/Refractory PMBCL
June 13th 2018The FDA has granted an accelerated approval to pembrolizumab for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or those who have relapsed after 2 or more prior lines of therapy.
Trastuzumab Deruxtecan Efficacious in Breast Cancer Across Varying HER2 Levels
June 13th 2018Long-term findings from a phase I study of trastuzumab deruxtecan showed that the investigational HER2-targeting antibody-drug conjugate had antitumor activity in multiple tumor types that expressed HER2 at varying levels.
FDA Approves Bevacizumab as Frontline Ovarian Cancer Treatment After Surgery
June 13th 2018The FDA has approved bevacizumab for use in combination with carboplatin and paclitaxel, followed by bevacizumab monotherapy, for the treatment of women with advanced ovarian cancer following initial surgical resection.
FDA Grants Venetoclax Full Approval for CLL, Regardless of 17p Deletion
June 8th 2018The FDA has granted a regular approval to venetoclax for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p deletion, following at least 1 prior therapy. The BCL-2 inhibitor is now also approved for use in combination with rituximab in the same patient population.