lunedì, 4 maggio 2026

Notizie AIOM – anno XVII

6 Settembre 2019

Pembrolizumab/Axitinib Combo Approved in Europe for Frontline RCC

Sep 4, 2019 - The European Commission has approved the combination of pembrolizumab and axitinib for the frontline treatment of patients with advanced renal cell carcinoma (RCC). The approval is based on findings from the phase III KEYNOTE-426 trial, in which the combination ...
Leggi tutto

6 Settembre 2019

5 settembre 2019 – AIFA: “Buon lavoro al nuovo Ministro della Salute”

5 Settembre 2019

2 settembre 2019 – Nota Informativa Importante su medicinali per nutrizione parenterale

5 Settembre 2019

3 settembre 2019 – Nota Informativa Importante su Blinatumomab (Amgen)

5 Settembre 2019

4 settembre 2019 – Parere preliminare della CTS su equivalenza terapeutica Sofosbuvir/Velpatasvir (Gilead) – Glecaprevir/Pibrentasvir (AbbVie)

5 Settembre 2019

Frontline Osimertinib Approved in China for EGFR+ NSCLC

Sep 4, 2019 - China’s National Medical Products Administration has approved osimertinib for the frontline treatment of adult patients with locally-advanced or metastatic non–small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 19 deletions or exon 21 ...
Leggi tutto

5 Settembre 2019

FDA Grants Neratinib Orphan Drug Status for Breast Cancer With Brain Metastases

Sep 3, 2019 - The FDA has granted an orphan drug designation to neratinib for the treatment of patients with breast cancer who have brain metastases. “Receiving Orphan Drug Designation from the FDA signifies our continued progress and commitment to developing treatments ...
Leggi tutto

5 Settembre 2019

Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma

Alterations in the gene encoding fibroblast growth factor receptor (FGFR) are common in urothelial carcinoma and may be associated with lower sensitivity to immune interventions. Erdafitinib, a tyrosine kinase inhibitor of FGFR1-4, has shown antitumor activity in preclinical ...
Leggi tutto

3 Settembre 2019

FDA Delays Decision on Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel in Nonsquamous NSCLC

Aug 30, 2019 - The FDA has extended the review period for a supplemental biologics license application (sBLA) for atezolizumab for use in combination with carboplatin and nab-paclitaxel as a first-line treatment for patients with metastatic nonsquamous non–small cell ...
Leggi tutto

3 Settembre 2019

FDA Recommendation on Duodenoscopes With Disposable Components

Aug 30, 2019 - The U.S. Food and Drug Administration (FDA) has recommended that duodenoscope manufacturers and health-care facilities transition to different types of duodenoscopes that may pose less risk to patient safety. Specifically, because of challenges with cleaning ...
Leggi tutto