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 Bi-weekly Teclistamab Dosing for Relapsed/Refractory Multiple Myeloma
February 20th 2024The FDA has approved a supplemental Biologics License Application for teclistamab-cqyv (Tecvayli) at a reduced dose of 1.5 mg/kg every 2 weeks in patients with relapsed/refractory multiple myeloma who have achieved and maintained a complete response or greater for at least 6 months.
FDA Approves Lifileucel for Unresectable or Metastatic Melanoma
February 16th 2024The FDA has approved lifileucel suspension (Amtagvi) for adult patients with unresectable or metastatic melanoma following prior treatment with a PD-1 inhibitor, and if BRAF V600 mutation positive, a BRAF inhibitor, with or without a MEK inhibitor.