One in three new cancer drugs brings no overall survival benefit

2017 ◽  
Keyword(s):  
Overall Survival ◽  
Survival Benefit ◽  
Cancer Drugs ◽  
Overall Survival Benefit

OP440 Comparison Of Evidence Supporting Cancer Drug Approvals And Prices In The US And Brazil

2021 ◽  
Vol 37 (S1) ◽  
pp. 16-17
Author(s):  
Adriana Ivama Brummell ◽  
Huseyin Naci
Keyword(s):  
Overall Survival ◽  
Survival Benefit ◽  
Therapeutic Benefit ◽  
Cancer Drug ◽  
Cancer Drugs ◽  
Drug Benefits ◽  
Drug Prices ◽  
The Us ◽  
Drug Approvals ◽  
Overall Survival Benefit

IntroductionCancer drug prices are high on the policy agenda worldwide. Previous research found no association between cancer drug benefits and prices at the time of regulatory approval. Drugs approved in the US with uncertain benefits may have spill-over effects in other settings. Our objective was to compare the evidence supporting cancer drug approvals in the US and Brazil, and to examine the association between cancer drug prices and availability of added therapeutic benefit.MethodsWe matched all novel cancer drugs approved in the US from 2010–2019 to approvals in Brazil. We extracted data on pivotal study design characteristics and outcomes in the US and Brazil, and evidence supporting price approval in Brazil, including availability of added therapeutic benefit.ResultsFrom 2010–2019, fifty-six cancer drugs with matching indications were approved in US and Brazil and had their prices authorized in Brazil by December 2020. Drug were available in Brazil following a median 522 days after US approval (IQR: 351–932). In the US, thirty-four (60.7 percent) of the drugs had pivotal randomized controlled trials (RCTs) and Twelve (21.4 percent) had overall survival benefit. By the time of Brazilian approval, forty-one (73.2 percent) drugs had pivotal RCTs and twenty-two (39.3 percent) had overall survival benefit. A total of twenty-eight (50 percent) drugs did not demonstrate added therapeutic benefit over other authorized drugs for the same indication and had a median reduction from requested to approved price of 6.1 percent (IQR: 0–27.8 percent) in Brazil. The twenty-seven (48.2 percent) drugs with added therapeutic benefit had a median price reduction of 2.0 percent (IQR: 0–9.2 percent).ConclusionsHalf of new cancer drugs approved in Brazil failed to demonstrate added therapeutic benefit. The Brazilian pricing system secured considerable price reductions, ensuring that prices for medicines with no added therapeutic benefit were not higher than existing treatments for the same approved indication. Although evidence was more mature by the time of Brazilian review, pivotal studies often lacked randomization and overall survival endpoints.

scholarly journals Novel Calculator to Estimate Overall Survival Benefit from Neoadjuvant Chemoradiation in Patients with Esophageal Adenocarcinoma

2017 ◽  
Vol 224 (5) ◽  
pp. 884-894.e1 ◽  
Author(s):  
Emmanuel Gabriel ◽  
Kristopher Attwood ◽  
Rupen Shah ◽  
Steven Nurkin ◽  
Steven Hochwald ◽  
...  
Keyword(s):  
Overall Survival ◽  
Esophageal Adenocarcinoma ◽  
Survival Benefit ◽  
Neoadjuvant Chemoradiation ◽  
Overall Survival Benefit

Partial resection offers an overall survival benefit over biopsy in MGMT-unmethylated IDH-wildtype glioblastoma patients

2020 ◽  
Vol 35 ◽  
pp. 515-519
Author(s):  
Giorgio Hallaert ◽  
Harry Pinson ◽  
Dimitri Vanhauwaert ◽  
Caroline Van den Broecke ◽  
Dirk Van Roost ◽  
...  
Keyword(s):  
Overall Survival ◽  
Survival Benefit ◽  
Partial Resection ◽  
Overall Survival Benefit

scholarly journals Overall Survival Benefit with Sipuleucel-T by Baseline Prostate-Specific Antigen (PSA): An Exploratory Analysis from Three Phase 3 Trials

2012 ◽  
Vol 23 ◽  
pp. ix310
Author(s):  
P. Kantoff ◽  
G. Chodak ◽  
R.B. Sims ◽  
J.B. Whitmore ◽  
P. Schellhammer
Keyword(s):  
Overall Survival ◽  
Prostate Specific Antigen ◽  
Survival Benefit ◽  
Specific Antigen ◽  
Exploratory Analysis ◽  
Phase 3 ◽  
Three Phase ◽  
Overall Survival Benefit
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