Notizie AIOM – anno XV n. 646
FDA Conducts Global Operation to Protect Consumers From Potentially Dangerous Prescription Drugs Sold Online
October 4, 2017 - The U.S. Food and Drug Administration (FDA), in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, ...Leggi tutto
Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement
The primary purposes of eligibility criteria are to protect the safety of trial participants and define the trial population. Excessive or overly restrictive eligibility criteria can slow trial accrual, jeopardize the generalizability of results, and limit understanding ...Leggi tutto
FDA Approves Higher-Dose Tablet of Brigatinib for NSCLC
October 3, 2017 - The FDA has approved a supplemental new drug application for the use of 180-mg tablets of brigatinib for the treatment of patients with non–small cell lung cancer (NSCLC). In April 2017, the FDA granted an accelerated approval to brigatinib as a treatment ...Leggi tutto
First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study
More than half of all patients with advanced urothelial cancer cannot receive standard, first-line cisplatin-based chemotherapy because of renal dysfunction, poor performance status, or other comorbidities. We assessed the activity and safety of first-line pembrolizumab ...Leggi tutto
Keap1 loss promotes Kras-driven lung cancer and results in dependence on glutaminolysis
Treating KRAS-mutant lung adenocarcinoma (LUAD) remains a major challenge in cancer treatment given the difficulties associated with directly inhibiting the KRAS oncoprotein. One approach to addressing this challenge is to define mutations that frequently co-occur with those ...Leggi tutto
Re-treatment with radium-223: first experience from an international, open-label, phase I/II study in patients with castration-resistant prostate cancer and bone metastases
Six radium-223 injections at 4-week intervals is indicated for patients with castration-resistant prostate cancer and symptomatic bone metastases. However, patients usually develop disease progression after initial treatment. This prospective phase I/II study assessed re-treatment ...Leggi tutto
Adjuvant Sunitinib for High-risk Renal Cell Carcinoma After Nephrectomy: Subgroup Analyses and Updated Overall Survival Results
Adjuvant sunitinib significantly improved disease-free survival (DFS) versus placebo in patients with locoregional renal cell carcinoma (RCC) at high risk of recurrence after nephrectomy (hazard ratio 0.76, 95% confidence interval 0.59-0.98; p=0.03). To report the relationship ...Leggi tutto