scholarly journals Frequency and level of evidence used in recommendations by the National Comprehensive Cancer Network guidelines beyond approvals of the US Food and Drug Administration: retrospective observational study

BMJ ◽  
2018 ◽  
pp. k668 ◽  
Author(s):  
Jeffrey Wagner ◽  
John Marquart ◽  
Julia Ruby ◽  
Austin Lammers ◽  
Sham Mailankody ◽  
...  
Keyword(s):  
Observational Study ◽  
National Comprehensive Cancer Network ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Retrospective Observational Study ◽  
Level Of Evidence ◽  
The Us ◽  
Cancer Network

scholarly journals Pan-Cancer Biomarkers: Changing the Landscape of Molecular Testing

2020 ◽  
Author(s):  
Jinjuan Yao ◽  
Maria E. Arcila ◽  
Marc Ladanyi ◽  
Jaclyn F. Hechtman
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Cancer Biomarkers ◽  
Molecular Testing ◽  
Clinical Settings ◽  
Sequencing Technologies ◽  
Mutation Burden ◽  
The Us ◽  
Cancer Network ◽  
Pan Cancer

Context.— The increasing use of large panel next-generation sequencing technologies in clinical settings has facilitated the identification of pan-cancer biomarkers, which can be diagnostic, prognostic, predictive, or most importantly, actionable. Objective.— To discuss recently approved and emerging pan-cancer and multihistology biomarkers as well as testing methodologies. Data Sources.— The US Food and Drug Administration approval documents, National Comprehensive Cancer Network guidelines, literature, and author's own publications. Conclusions.— Since 2017, the US Food and Drug Administration has approved genotype-directed therapies for pan-cancer biomarkers, including microsatellite instability, neurotrophic receptor kinases fusions, and high-tumor mutation burden. Both the importance and rarity of these biomarkers have increased the prevalence of genomic profiling across solid malignancies. As an integral part of the management team of patients with advanced cancer, pathologists need to be aware of these emerging biomarkers, the therapies for which they determine eligibility, and the strengths and pitfalls of the available clinical assays.

scholarly journals Benefit, burden, and impact for a cohort of post-approval cancer combination trials

2019 ◽  
Vol 17 (1) ◽  
pp. 18-29 ◽  
Author(s):  
Benjamin Gregory Carlisle ◽  
Adélaïde Doussau ◽  
Jonathan Kimmelman
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
National Comprehensive Cancer Network ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Guideline Recommendation ◽  
Anti Cancer ◽  
Grade 3 ◽  
Cancer Network

Background: After approval, drug developers often pursue trials aimed at extending the uses of a new drug by combining it with other drugs. Little is known about the risk and benefits associated with such research. Methods: To establish a historic benchmark of risk and benefit, we searched Medline and Embase for clinical trials testing anti-cancer drugs in combination within 5 years of approval by the Food and Drug Administration of 12 anti-cancer “index” drugs first licensed 2005–2007 inclusive. Risk was assessed based on grade 3 or above drug-related adverse events; benefit was assessed based on efficacy outcomes and advancement of combinations into clinical practice guidelines or approval by the Food and Drug Administration. Results: We captured 323 published post-approval trials exploring combinations, including 266 unique combination–indication pairings and enrolling 29,835 patients. The pooled risk ratios for treatment-related grade 3–4 severe adverse events and deaths attributed to the study drugs for trials randomized between a combination arm and a comparator were 1.54 (1.33–1.79) and 1.51 (1.16–1.97), respectively. The pooled hazard ratios for overall survival and progression-free survival were 0.99 (0.92–1.05) and 0.85 (0.79–0.93), respectively. None of the combination–indication pairings launched after initial drug approval received approval by the Food and Drug Administration, and 13 pairings (4.9%) were recommended by the National Comprehensive Cancer Network within 5 years of the first trial within that pairing. The proportion of patients in our sample who participated in trials leading to an approval by the Food and Drug Administration or a National Comprehensive Cancer Network guideline recommendation was 12.7% with 5 years of follow-up, and 22.3% among pairings for which there were 8 years of follow-up. Conclusion: Patients were just as likely to benefit in the treatment arm as the control arm in terms of overall survival, but they were more likely to experience a treatment-related severe adverse event in post-approval trials of combination therapy.

scholarly journals 2020 FDA TIDES (Peptides and Oligonucleotides) Harvest

2021 ◽  
Vol 14 (2) ◽  
pp. 145
Author(s):  
Othman Al Musaimi ◽  
Danah Al Shaer ◽  
Fernando Albericio ◽  
Beatriz de la Torre
Keyword(s):  
Adverse Effects ◽  
Global Health ◽  
Drug Administration ◽  
Mode Of Action ◽  
Chemical Structure ◽  
Food And Drug Administration ◽  
Health Crisis ◽  
New Drug ◽  
Target Mode ◽  
The Us

2020 has been an extremely difficult and challenging year as a result of the coronavirus disease 2019 (COVID-19) pandemic and one in which most efforts have been channeled into tackling the global health crisis. The US Food and Drug Administration (FDA) has approved 53 new drug entities, six of which fall in the peptides and oligonucleotides (TIDES) category. The number of authorizations for these kinds of drugs has been similar to that of previous years, thereby reflecting the consolidation of the TIDES market. Here, the TIDES approved in 2020 are analyzed in terms of chemical structure, medical target, mode of action, and adverse effects.

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