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.
NCCN Grants Category 1 Recommendation to Pexidartinib for TGCT
September 27th 2019The National Comprehensive Cancer Network has updated its Clinical Practice Guidelines in Oncology for Soft Tissue Sarcoma to include a category 1 recommendation for pexidartinib (Turalio) for the treatment of patients with tenosynovial giant cell tumor.
FDA Approves Frontline Daratumumab Regimen for Transplant-Eligible Myeloma
September 26th 2019The FDA has approved daratumumab in combination with bortezomib, thalidomide, and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
Blinatumomab Studies Stopped Early for Clinical Benefit in Pediatric Relapsed ALL
September 25th 2019Two clinical trials evaluating blinatumomab compared with chemotherapy in pediatric patients with acute lymphoblastic leukemia were stopped early due to treatment benefit with the bispecific T-cell engager.
EU Panel Recommends 4-Week Nivolumab Dosing Schedule in Adjuvant Melanoma
September 24th 2019The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of nivolumab at a flat dosing schedule of either 240 mg over 30 minutes every 2 weeks, or 480 mg infused over 60 minutes every 4 weeks, for the adjuvant treatment of patients with melanoma who have involvement of lymph nodes or metastatic disease who have undergone complete resection.
Brentuximab Vedotin and Nivolumab Explored in Frontline Hodgkin Lymphoma Regimen
September 23rd 2019The addition of the antibody-drug conjugate brentuximab vedotin and the PD-1 inhibitor nivolumab to chemotherapy in patients with stage I/II Hodgkin lymphoma is under investigation in an ongoing phase II trial (NCT03233347).
Gilteritinib Approaches EU Approval for FLT3-Mutant AML
September 21st 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of gilteritinib as a single agent for the treatment of adult patients with relapsed/refractory acute myeloid leukemia who have FLT3 mutations.
Regulatory Decisions, New Data Propel Progress With Biosimilars in Oncology
September 21st 2019The uptick of biosimilars has led to a surge of new data and regulatory decisions in recent years, with a focus on similarity between biosimilars and their reference products while reducing healthcare costs. This week, data on subcutaneous formulations of one biosimilar and long-term experience with another were provided, as well as an authorization of a trastuzumab (Herceptin) biosimilar in Canada.