Notizie AIOM – anno XV
FDA Tackles Drug Competition to Improve Patient Access
June 27, 2017 - Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded ...Leggi tutto
FDA unveils plan to eliminate orphan designation backlog
June 29, 2017 - Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s ...Leggi tutto
FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas
June 29, 2017 - The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute ...Leggi tutto
FDA Approves First-Line Panitumumab for RAS Wild-Type mCRC
June 30, 2017 - The FDA has approved panitumumab in combination with FOLFOX as a frontline treatment for patients with RAS wild-type metastatic colorectal cancer (mCRC), according to Amgen, the company marketing the anti-EGFR antibody. In addition to the frontline approval, ...Leggi tutto
EU Approves Frontline Ceritinib for ALK+ NSCLC
June 29, 2017 - The European Union (EU) has approved the use of ceritinib for the first-line treatment of patients with ALK-positive advanced nonsmall cell lung cancer (NSCLC). Novartis, the manufacturer of the selective ALK-inhibitor, announced the approval in a press ...Leggi tutto
Web-app
Una nuova web-app gratuita, in otto lingue, per computer, tablet e smartphone sul melanoma è disponibile sul sito del Corriere della Sera in collaborazione con l'Associazione Italiana di Oncologia Medica (leggi e scarica). Strumento interattivo in due versioni, per ...Leggi tutto
The impact of baseline Edmonton Symptom Assessment Scale scores on treatment and survival in patients with advanced non-small cell lung cancer
Palliative systemic therapy is frequently underutilsed in patients with advanced non-small cell lung cancer, for many reasons. The aim of this study was to identify patient-reported factors that may predict for treatment decisions and survival in advanced NSCLC, using the ...Leggi tutto
Randomized, Noncomparative, Phase II Trial of Early Switch from Docetaxel to Cabazitaxel or Vice Versa,With Integrated Biomarker Analysis, in Men With Chemotherapy-Naïve, Metastatic, Castration-Resistant Prostate Cancer
The TAXYNERGY trial clinical benefit from early taxane switch and circulating tumor cell (CTC) biomarkers to interrogate mechanisms of sensitivity or resistance to taxanes in men with chemotherapy-naïve, metastatic, castration-resistant prostate cancer. Patients were ...Leggi tutto