Notizie AIOM – anno XVII
FDA Approvals Represent New Wave of Progress in Advanced HCC
April 15, 2019 - Until recently, sorafenib was the only FDA-approved systemic therapy for the treatment of patients with unresectable hepatocellular carcinoma (HCC). Now, lenvatinib, regorafenib, cabozantinib, nivolumab, pembrolizumab, and ramucirumab have been added to ...Leggi tutto
FDA Expands Approval of PD-L1 IHC 22C3 pharmDX Assay in NSCLC
April 17, 2019 - The FDA has expanded the approval of the PD-L1 IHC 22C3 pharmDX assay, allowing the test to be used as a companion diagnostic to identify more patients with stage III or metastatic non–small cell lung cancer (NSCLC) who can undergo first-line treatment ...Leggi tutto
FDA Lowers Pembrolizumab PD-L1 Cutoff in NSCLC, Expands Approval to Stage III
April 11, 2019 - The FDA has expanded the approval for pembrolizumab monotherapy for the frontline treatment of patients with stage III non–small cell lung cancer (NSCLC), who are ineligible for surgery or definitive chemoradiation, or metastatic NSCLC, with a PD-L1 ...Leggi tutto
Opioid-Related Hospitalizations Among Patients With Cancer in the United States
April 12, 2019 - In a study reported in a research letter in JAMA Oncology, Chua et al found that opioid-related hospitalizations among American patients with cancer are rare, increasing at a very low rate, and consist mostly of hospitalization for nonheroin opioid poisoning. ...Leggi tutto
FDA approves first targeted therapy for metastatic bladder cancer
April 12, 2019 - The U.S. Food and Drug Administration today granted accelerated approval to Erdafitinib, a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that ...Leggi tutto
Update of EU recommendations for 2019/2020 seasonal flu vaccine composition
April 12, 2019 - EMA has issued an PDF iconupdate of the EU recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2019. The recommendations now also contain a decision on ...Leggi tutto
Entrectinib Data Highlighted as FDA Weighs Approval for ROS1+ NSCLC
April 11, 2019 - Patients with ROS1-positive non–small cell lung cancer (NSCLC) showed high response rates and durable responses following treatment with entrectinib, according to findings from a pooled analysis of 3 studies presented at the 2019 European Lung Cancer ...Leggi tutto
Trends in Checkpoint Inhibitor Therapy for Advanced Urothelial Cell Carcinoma at the End of Life: Insights from Real‐World Practice
Several immune checkpoint inhibitor therapies (CPIs) have been approved to treat metastatic urothelial cell carcinoma (mUC). Because of the favorable toxicity profile of CPI compared with chemotherapy, oncologists may have a low threshold to prescribe CPI to patients near ...Leggi tutto
The role of regulators in establishing added benefit of novel therapies
April 11, 2019 - Regulators have a role to play in ensuring that there is a solid evidence base to support the assessment of added therapeutic benefit of novel treatments compared with existing and potentially cheaper therapies. To help health technology assessment bodies, ...Leggi tutto