Notizie AIOM – anno XVII
FDA Approval Sought for Ibrutinib/Rituximab in Frontline CLL/SLL
November 8, 2019 - A supplemental new drug application (sNDA) has been submitted to the FDA for ibrutinib for use in combination with rituximab for the first-line treatment of patients ≤70 years old with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma ...Leggi tutto
FDA approves first therapy to treat patients with rare blood disorder
November 8, 2019 - Today the U.S. Food and Drug Administration granted approval to luspatercept–aamt for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. “When patients ...Leggi tutto
ASCO Congratulates Stephen M. Hahn, MD, FASTRO, on Nomination to Serve as FDA Commissioner
November 1, 2019 - Based on strong findings for efficacy and safety, as well as FDA approvals, the Society for Immunotherapy of Cancer (SITC) has issued the first guidelines for the use of immunotherapy agents in patients with recurrent or metastatic (RM) head and neck squamous ...Leggi tutto
Statement on the agency’s efforts to protect patients through postmarket drug safety surveillance practices
November 6, 2019 - Public health and safety is the highest priority at the U.S. Food and Drug Administration. We maintain a robust practice of postmarket surveillance and risk evaluation programs to identify new adverse events that did not appear during the product development ...Leggi tutto
Quality of life analysis in lung cancer: a systematic review of phase III trials published between 2012 and 2018
We previously reported that quality of life (QoL) is not included among trial endpoints and QoL results are underreported in a significant proportion of phase III oncology trials. Here we describe QoL adoption, reporting and methodology of QoL analysis in lung cancer trials. ...Leggi tutto
Indirect Comparisons of Efficacy between Combination Approaches in Metastatic Hormone-sensitive Prostate Cancer: A Systematic Review and Network Meta-analysis
There have been substantial changes in the management of men with metastatic hormone-sensitive prostate cancer (mHSPC) over the past 5 yr, with upfront combination therapies replacing androgen-deprivation therapy (ADT) alone. A range of therapies have entered the space ...Leggi tutto
Final results of a prospective study of scalp cooling in preventing chemotherapy-induced alopecia
Alopecia is a distressing effect of cancer treatments. Our study examined efficacy and safety of scalp cooling to prevent chemotherapy-induced alopecia. Early breast cancer patients candidate to anthracycline and/or taxane were eligible. Dean's alopecia scale was used to ...Leggi tutto