Results for 'NCCN'
Consolación Molto MD, Thomas J. Hwang AB, Maria Borrell MD, Marta Andres MD, Ignasi Gich MD, PhD, Agustí Barnadas MD, PhD, Eitan Amir MD, PhD, Aaron S. Kesselheim MD, JD, MPH, Ariadna Tibau MD, PhD
Clinical benefit and cost of breakthrough cancer drugs approved by the US Food and Drug Administration
USFDA, ESMO-MCBS, NCCN, ASCO-CRC, clinical, drug aroval
The study evaluates the clinical benefit and pricing of breakthrough-designated versus non-breakthrough-designated cancer drugs. The analysis covers approvals from July 2012 to December 2017, using frameworks like ASCO-VF, ASCO-CRC, ESMO-MCBS, and NCCN Evidence Blocks. High clinical benef…
Jul 22nd • 12 mins read
Bishal Gyawali, Benjamin N Rome, Aaron S Kesselheim
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
clinical guidelines, FDA, accelerated approval cancer drugs, surrogate measures, NCCN, EMA
Six of 18 cancer drugs that initially received accelerated approval have indications that remain on the labeling and are recommended in clinical guidelines despite no improvement in the primary endpoint in post-approval trials. These findings reflect the lack of fulfillment of the compromise between…
Aug 4th • 12 mins read
R. Kurzrock, L.A. Gurski, R.W. Carlson, D.S. Ettinger, S.M. Horwitz, S.K. Kumar, L. Million, M. von Mehren, A.B. Benson III
Level of evidence used in recommendations by the National Comprehensive Cancer Network (NCCN) guidelines beyond Food and Drug Administration approvals
oncology, guidelines, off-label drug use
The analysis reviewed 113 NCCN recommendations, focusing on 44 off-label uses of drugs. 14 of these off-label recommendations were later FDA-approved or backed by RCT data. 13 recommendations were minor extrapolations from the FDA label or actually on-label. Of the remaining 17 extrapolations…
Aug 2nd • 8 mins read
Consolacion Molto, Ariadna Tibau, Aida Bujosa, Jose Carlos Tapia, Abhenil Mittal, Faris Tamimi & Eitan Amir
Association between control group therapy and magnitude of clinical benefit of cancer drugs
control group therapy, clinical benefit scales, ESMO-MCBS, ASCO-VF, randomized trials
The study investigated the impact of control group therapy on various clinical benefit scales like ASCO-VF, ESMO-MCBS, NCCN Evidence Blocks, and ASCO-CRC. Researchers analyzed cancer drugs approved between 2012 and 2021 using data from randomized controlled trials (RCTs) listed on Drugs@FDA. Sig…
Dec 9th • 20 mins read