Notizie AIOM – anno XVII
ASCO Announces 2019-20 Health Policy Leadership Development Program Fellows
May 29, 2019 - The American Society of Clinical Oncology (ASCO) today announced the Health Policy Leadership Development Program Fellows for the 2019-2020 class. Wendy Allen-Rhoades, MD, of Baylor College of Medicine, and Laura LaNiel Tenner, MD, MPH, of The Mays Cancer ...Leggi tutto
FDA Approves Lenalidomide/Rituximab for Indolent Non-Hodgkin Lymphoma
May 28, 2019 - The FDA has approved the R2 regimen of lenalidomide plus rituximab for use in patients with previously treated follicular lymphoma and marginal zone lymphoma (MZL). The approval was primarily based on the phase III AUGMENT trial, in which the R2 regimen reduced ...Leggi tutto
FDA Grants Fast Track Designation to ARV-110 for mCRPC
May 29, 2019 - The FDA has granted a fast track designation to ARV-110, a protein degrader, for use as a treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have disease progression following ≥2 systemic therapies. The orally bioavailable ...Leggi tutto
FDA Grants Copanlisib Breakthrough Designation for MZL
May 30, 2019 - The FDA has granted copanlisib a breakthrough therapy designation for the treatment of adult patients with relapsed marginal zone lymphoma (MZL) who have received at least 2 prior therapies, according to Bayer, the manufacturer of the PI3K inhibitor. The designation, ...Leggi tutto
COTA, FDA Agree to Collaborate on Breast Cancer Research
May 30, 2019 - COTA, Inc., a leading precision medicine technology company, has signed a 2-year Research Collaboration Agreement (RCA) with the FDA’s Information Exchange and Data Transformation (INFORMED) program. The agreement establishes a study protocol for research ...Leggi tutto
Statement on FDA’s request for information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids
May 30, 2019 - The opioid tragedy has become one of the defining public health crises of modern times. As the rates of opioid addiction and overdose continue to grow, addressing the opioid crisis has taken on more urgency. For the past few years, the U.S. Food and Drug Administration ...Leggi tutto
FDA Approval Sought for Tazemetostat for Epithelioid Sarcoma
May 30, 2019 - A new drug application (NDA) has been submitted to the FDA for tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery, according to Epizyme, the manufacturer of the EZH2 inhibitor. ...Leggi tutto
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-29 May 2019
May 29, 2019 - EMA’s human medicines committee (CHMP) recommended four medicines for approval at its May 2019 meeting. The Committee recommended granting a marketing authorisation for trientine dihydrochloride, for the treatment of Wilson’s disease, a rare inherited ...Leggi tutto