Notizie Newsletter
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
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
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
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
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
Atezolizumab Plus Nab-Paclitaxel Approved in Europe for Frontline TNBC
Aug 29, 2019 - The European Commission (EC) has approved the frontline combination of atezolizumab plus nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer (TNBC), according ...Leggi tutto
Global public meeting on draft ICH guideline on clinical trials
Aug 30, 2019 - The global guidance for the conduct of clinical trials is currently undergoing a major revision. As part of the worldwide consultation process, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is ...Leggi tutto