lunedì, 4 maggio 2026

Notizie AIOM – anno XVII

FDA Approves Fourth Trastuzumab Biosimilar

March 11, 2019 - The FDA has granted an approval to PF-05280014 (trastuzumab-qyyp), a trastuzumab biosimilar, to treat patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. This marks ...
Leggi tutto

Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars

March 13, 2019 - When we first announced our comprehensive plan for tobacco and nicotine regulation in July 2017, we outlined a framework to better protect kids and to significantly reduce tobacco-related disease and death. We are continuing to implement that framework today. ...
Leggi tutto

Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development

March 14, 2019 - Modernizing clinical trials is an agency wide priority. As more diseases are being redefined based on genomic subtype, researchers have more novel targets and more opportunities to precisely modulate or even repair the basic biological drivers of illness. ...
Leggi tutto

EMA now operating from Amsterdam

March 11, 2019 - As of today, EMA is operating from Amsterdam. EMA left its London premises on 1 March, and following a transitional week of teleworking, its staff will gradually move throughout this week into the Spark building in Amsterdam Sloterdijk. The Agency has been ...
Leggi tutto

UK Grants EAMS Positive Opinion to Atezolizumab Combo in Frontline TNBC

March 14, 2019 - The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted an Early Access to Medicines Scheme (EAMS) positive scientific opinion to atezolizumab in combination with nab-paclitaxel for patients with unresectable locally ...
Leggi tutto

Frontline Atezolizumab Regimen Approved in Europe for NSCLC

March 8, 2019 - The European Commission has approved and granted marketing authorization to the frontline combination of atezolizumab, bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic, nonsquamous non–small cell lung ...
Leggi tutto

Changes in health-related quality of life among gynecologic cancer survivors during the two years after initial treatment: a longitudinal analysis

While many cancer survivors experience persistent impairments in health-related quality of life (HRQoL) for extended periods of time, others recover soon after treatment. The aim of this research is to assess changes in health-related quality of life in endometrial and ovarian ...
Leggi tutto

Durable Tumor Regression and Overall Survival in Patients With Advanced Merkel Cell Carcinoma Receiving Pembrolizumab as First-Line Therapy

Merkel cell carcinoma (MCC) is an aggressive skin cancer often caused by the Merkel cell polyomavirus. Clinical trials of programmed cell death-1 pathway inhibitors for advanced MCC (aMCC) demonstrate increased progression-free survival (PFS) compared with historical chemotherapy ...
Leggi tutto

Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma

The combination of pembrolizumab and axitinib showed antitumor activity in a phase 1b trial involving patients with previously untreated advanced renal-cell carcinoma. Whether pembrolizumab plus axitinib would result in better outcomes than sunitinib in such patients was ...
Leggi tutto

8 marzo 2019 – AIFA rivede criteri di accesso e prezzi dei Nuovi Anticoagulanti Orali (NAO): più salute a parità di risorse