Notizie AIOM – anno XVII n. 708
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 2019
February 1, 2019 - EMA’s human medicines committee (CHMP) recommended six medicines for approval at its January 2019 meeting. The CHMP adopted a positive opinion for Fremanezumab, for the prophylaxis of migraine. Dacomitinib received a positive opinion for the treatment ...Leggi tutto
Dacomitinib Approaches EU Approval for EGFR+ NSCLC
February 1, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of dacomitinib for the frontline treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) with EGFR-activating ...Leggi tutto
EU Panel Backs Frontline Atezolizumab Regimen in NSCLC
February 1, 2019 - The European Medicine’s Agency Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the frontline combination of atezolizumab, bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic, ...Leggi tutto
NICE Recommends Tisagenlecleucel for Relapsed/Refractory DLBCL
February 1, 2019 - The UK’s National Institute for Health and Care Excellence has authorized the use of the CAR T-cell therapy tisagenlecleucel for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who have received ≥2 lines ...Leggi tutto
FDA Approves Ibrutinib Plus Obinutuzumab in Frontline CLL/SLL
January 28, 2019 - The FDA has approved the combination of ibrutinib and obinutuzumab for the first-line treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The decision is based on results from the phase III iLLUMINATE (PCYC-1130) ...Leggi tutto
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to enhance the utility of the Orange Book to foster drug competition
January 30, 2019 - One of our key policy priorities is encouraging the timely development and approval of generics and biosimilars. Our efforts have helped foster competition in the marketplace with the ultimate goal of improving access to high quality, affordable treatment ...Leggi tutto
2018 Update of WHO-EORTC Classification of Primary Cutaneous Lymphomas
January 29, 2019 - As reported by Willemze and colleagues in Blood, the World Health Organization (WHO) and the European Organisation for Research and Treatment of Cancer (EORTC) have released a 2018 update of their classification of primary cutaneous lymphomas. As noted ...Leggi tutto