Notizie AIOM – anno XVII
FDA Grants Frontline Daratumumab Regimen Priority Review in Transplant-Eligible Myeloma
May 31, 2019 - The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for daratumumab in combination with bortezomib, thalidomide, and dexamethasone (VTd) for the treatment of patients with newly diagnosed multiple myeloma ...Leggi tutto
FDA Grants Lasofoxifene Fast Track Designation for ER+/ESR1-Mutant Metastatic Breast Cancer
May 29, 2019 - The FDA has granted a fast track designation to lasofoxifene for use as a treatment of female patients with estrogen receptor (ER)–positive, HER2-negative metastatic breast cancer who harbor ESR1 mutations. The investigational agent is being evaluated ...Leggi tutto
FDA Updates Gilteritinib AML Label With OS Data
May 30, 2019 - The FDA approved a supplemental new drug application (sNDA) to update the label for gilteritinib to include final analysis data from the phase III ADMIRAL trial, which demonstrated an improvement in overall survival with the FLT3 inhibitor compared with salvage ...Leggi tutto
EMA Accepts Application for Trastuzumab Biosimilar
May 29, 2019 - The European Medicines Agency (EMA) has validated and accepted a marketing authorization application for the trastuzumab biosimilar HD201, according to the developer Prestige BioPharma. The application is based on findings from a phase I study and the phase ...Leggi tutto
Treatment and Long-Term Clinical Outcomes of Incidental Pulmonary Embolism in Patients With Cancer: An International Prospective Cohort Study
Pulmonary embolism is incidentally diagnosed in up to 5% of patients with cancer on routine imaging scans. The clinical relevance and optimal therapy for incidental pulmonary embolism, particularly distal clots, is unclear. The aim of the current study was to assess current ...Leggi tutto
Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval
The US Food and Drug Administration’s (FDA’s) accelerated approval pathway allows investigational cancer drugs to be approved by demonstrating a beneficial effect on a surrogate measure (eg, progression-free survival) that is expected to predict a real clinical ...Leggi tutto