Notizie AIOM – anno XVII
Efficacy and safety of niraparib as maintenance treatment in older patients (≥70years) with recurrent ovarian cancer: Results from the ENGOT-OV16/NOVA trial
To analyze the safety and efficacy of niraparib in patients aged ≥70 years with recurrent ovarian cancer in the ENGOT-OV16/NOVA trial. The trial enrolled 2 independent cohorts with histologically diagnosed recurrent ovarian, fallopian tube, or peritoneal cancer ...Leggi tutto
FDA Grants Pomalidomide Breakthrough Designation in Kaposi Sarcoma
May 13, 2019 - The FDA has granted a breakthrough therapy designation to pomalidomide for use as a treatment for patients with HIV-positive Kaposi sarcoma who have received prior chemotherapy, as well as patients with HIV-negative Kaposi sarcoma. The designation was based ...Leggi tutto
FDA Grants P-BCMA-101 CAR T-Cell Therapy Orphan Drug Designation for Myeloma
May 14, 2019 - The FDA has granted an orphan drug designation to the autologous CAR T-cell therapy P-BCMA-101 for the treatment of patients with relapsed/refractory multiple myeloma. The designation is based on results of a phase I trial (NCT03288493), which demonstrated ...Leggi tutto
FDA Grants Fast Track Designation to Leronlimab for Metastatic TNBC
May 7, 2019 - The FDA has granted a fast track designation to the CCR5 antagonist leronlimab (PRO140) for use in combination with carboplatin for the treatment of patients with CCR5-positive metastatic triple-negative breast cancer (TNBC). The agent, which is administered ...Leggi tutto
Statement from Acting FDA Commissioner Ned Sharpless, M.D., on policy advancements to help bring interchangeable biosimilars to market
May 10, 2019 - The U.S. Food and Drug Administration plays an important role in helping to address the high cost of medicines through the development of science-based policies that can improve competition and patient access to safe and effective, high-quality and lower cost ...Leggi tutto