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 Tisagenlecleucel for Large B-Cell Lymphoma
May 2nd 2018The FDA has approved tisagenlecleucel (Kymriah) for use in adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma—after 2 or more lines of systemic therapy.
FDA Grants Priority Review to Cemiplimab in CSCC
April 30th 2018The FDA has granted a priority review to a biologics license application for the PD-1 inhibitor cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not eligible for surgery.
European Panel Backs Carfilzomib Label Update in Myeloma
April 30th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended adding final overall survival data from the phase III ASPIRE trial to the label for carfilzomib for the treatment of patients with relapsed/refractory multiple myeloma.
FDA Grants Priority Review for Full Approval of Frontline Pembrolizumab Combo in NSCLC
April 30th 2018The FDA has granted a priority review to a supplemental biologics license application for frontline pembrolizumab for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer.
Frontline Osimertinib Approaches European Approval for NSCLC
April 27th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of osimertinib as a first-line treatment for patients with non–small cell lung cancer (NSCLC) whose tumors harbor activating EGFR mutations.
Gemtuzumab Ozogamicin Approved in Europe for CD33+ AML
April 25th 2018The European Commission has approved the antibody-drug conjugate gemtuzumab ozogamicin (Mylotarg) for use in combination with daunorubicin and cytarabine for the treatment of patients aged 15 years and older with newly diagnosed, CD33-positive acute myeloid leukemia, except acute promyelocytic leukemia.