Notizie AIOM – anno XVII
FDA Grants Durvalumab Priority Review for Frontline Small Cell Lung Cancer
December 2, 2019 - The FDA has granted a priority review designation to a supplemental Biologics License Application (sBLA) for durvalumab for the frontline treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). The sBLA is based on findings from phase ...Leggi tutto
FDA Grants Pembrolizumab Priority Review for High-Risk NMIBC
December 2, 2019 - The FDA has granted a priority review designation to pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin (BCG)–unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without ...Leggi tutto
FDA Schedules ODAC Meeting on Tazemetostat for Epithelioid Sarcoma
December 3, 2019 - The FDA has scheduled an Oncology Drugs Advisory Committee (ODAC) hearing for December 18, 2019, to discuss data supporting a new drug application (NDA) for tazemetostat as a treatment for patients with metastatic or locally advanced epithelioid sarcoma ...Leggi tutto
FDA Panel to Review Application for Luspatercept in MDS
December 3, 2019 - The FDA’s Oncologic Drugs Advisory Committee (ODAC) has scheduled a hearing for December 18, 2019, to review a supplemental Biologics License Application (sBLA) for luspatercept-aamt for use as a treatment for patients with myelodysplastic syndromes ...Leggi tutto
FDA Grants Abatacept Breakthrough Designation for Acute GVHD
December 4, 2019 - The FDA has granted a breakthrough therapy designation for abatacept for the prevention of moderate-to-severe acute graft-versus-host disease (GVHD) in patients who have undergone hematopoietic stem cell transplants (HSCTs) from unrelated donors. The designation ...Leggi tutto
NICE Approves Palbociclib Combo for HR+ Advanced Breast Cancer
December 2, 2019 - The UK National Institute for Health and Care Excellence (NICE) has approved palbociclib in combination with fulvestrant for the treatment of female patients with hormone receptor (HR)–positive, HER2-negative locally advanced or metastatic breast ...Leggi tutto
Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial
Immunotherapy in combination with chemotherapy has shown promising efficacy across many different tumour types. We report the prespecified second interim overall survival analysis of the phase 3 IMpassion130 study assessing the efficacy and safety of atezolizumab plus nab-paclitaxel ...Leggi tutto
Polypharmacy, Inappropriate Medication Use, and Drug Interactions in Older Korean Patients with Cancer Receiving First‐Line Palliative Chemotherapy
Polypharmacy is an important issue in the care of older patients with cancer, as it increases the risk of unfavorable outcomes. We estimated the prevalence of polypharmacy, potentially inappropriate medication (PIM) use, and drug–drug interactions (DDIs) in older patients ...Leggi tutto
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 Novemver 2019
November 29, 2019 - At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update ...Leggi tutto