Publisher Correction: Breast cancer drug approvals by the US FDA from 1949 to 2018

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.

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The US FDA has withdrawn approval of the breast cancer indication for bevacizumab [Avastin],

Reactions Weekly ◽

10.2165/00128415-201113790-00002 ◽

2011 ◽

Vol &NA; (1379) ◽

pp. 2

Author(s):

&NA;

Keyword(s):

Breast Cancer ◽

The Us ◽

Us Fda

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The NCI* and the US FDA are collaborating on a cancer drug development programme,

Inpharma Weekly ◽

10.2165/00128413-200313900-00004 ◽

2003 ◽

Vol &NA; (1390) ◽

pp. 3

Author(s):

&NA;

Keyword(s):

Drug Development ◽

Development Programme ◽

Cancer Drug ◽

The Us ◽

Us Fda ◽

Drug Development Programme

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Potential Utility of Pre-Emptive Germline Pharmacogenetics in Breast Cancer

Cancers ◽

10.3390/cancers13061219 ◽

2021 ◽

Vol 13 (6) ◽

pp. 1219

Author(s):

Philip S. Bernard ◽

Whitney Wooderchak-Donahue ◽

Mei Wei ◽

Steven M. Bray ◽

Kevin C. Wood ◽

...

Keyword(s):

Breast Cancer ◽

Side Effects ◽

Adverse Events ◽

Proton Pump ◽

Gene Interactions ◽

Potential Utility ◽

Dose Selection ◽

The Us ◽

Inflammatory Drugs ◽

Us Fda

Patients with breast cancer often receive many drugs to manage the cancer, side effects associated with cancer treatment, and co-morbidities (i.e., polypharmacy). Drug–drug and drug–gene interactions contribute to the risk of adverse events (AEs), which could lead to non-adherence and reduced efficacy. Here we investigated several well-characterized inherited (germline) pharmacogenetic (PGx) targets in 225 patients with breast cancer. All relevant clinical, pharmaceutical, and PGx diplotype data were aggregated into a single unifying informatics platform to enable an exploratory analysis of the cohort and to evaluate pharmacy ordering patterns. Of the drugs recorded, there were 38 for which high levels of evidence for clinical actionability with PGx was available from the US FDA and/or the Clinical Pharmacogenetics Implementation Consortium (CPIC). These data were associated with 10 pharmacogenes: DPYD, CYP2C9, CYP2C19, CYP2D6, CYP3A5, CYP4F2, G6PD, MT-RNR1, SLCO1B1, and VKORC1. All patients were taking at least one of the 38 drugs and had inherited at least one actionable PGx variant that would have informed prescribing decisions if this information had been available pre-emptively. The non-cancer drugs with PGx implications that were common (prescribed to at least one-third of patients) included anti-depressants, anti-infectives, non-steroidal anti-inflammatory drugs, opioids, and proton pump inhibitors. Based on these results, we conclude that pre-emptive PGx testing may benefit patients with breast cancer by informing drug and dose selection to maximize efficacy and minimize AEs.

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INSIDE INDUSTRY

Asia-Pacific Biotech News ◽

10.1142/s021903031900020x ◽

2019 ◽

Vol 23 (03) ◽

pp. 36-38

Keyword(s):

Breast Cancer ◽

Early Breast Cancer ◽

Kidney Cancer ◽

Patient Information ◽

Cancer Drug ◽

Molecular Test ◽

Infection Treatment ◽

The Us ◽

Access Program ◽

Hiv 1

Entries open for the US$170,000 Ryman Prize. Digital chemotherapy pill that senses and transmit patient information. Singapore HSA approves HIV-1 infection treatment for adults. New early breast cancer drug available in Singapore via special access program. Molecular test to predict immunotherapy response for kidney cancer.

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Recent drug approvals from the US FDA and EMEA: what the future holds

Future Medicinal Chemistry ◽

10.4155/fmc.09.8 ◽

2009 ◽

Vol 1 (1) ◽

pp. 35-48 ◽

Cited By ~ 4

Author(s):

Paolo Pevarello

Keyword(s):

The Us ◽

The Future ◽

Drug Approvals ◽

Us Fda

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An estimate of rate of deviation from NCCN guideline recommendations for central nervous system imaging in trials forming basis for drug approval in first line advanced non-small cell lung cancer (NSCLC)

BMC Cancer ◽

10.1186/s12885-022-09179-y ◽

2022 ◽

Vol 22 (1) ◽

Author(s):

John Sharp ◽

Vinay Prasad

Keyword(s):

Advanced Nsclc ◽

Standard Of Care ◽

Drug Approval ◽

First Line ◽

Recommended Care ◽

Nccn Guidelines ◽

The Us ◽

Trial Protocols ◽

Drug Approvals ◽

Us Fda

Abstract Importance It is unknown whether and to what degree trials submitted to the US FDA to support drug approval adhere to NCCN guideline-recommended care in their baseline and surveillance CNS imaging protocols. Objective We sought to characterize the frequency with which the trials cited in US FDA drug approvals for first line advanced NSCLC between 2015 and 2020 deviated from NCCN guideline-recommended care for baseline and surveillance CNS imaging. Design, setting, and participants Retrospective observational analysis using publicly available data of (1) list of trials cited by the FDA in drug approvals for first line advanced NSCLC from 2015 to 2020 (2) individual trial protocols (3) published trial data and supplementary appendices (4) archived versions of the NCCN guidelines for NSCLC from 2009 to 2018 (the years during which the trials were enrolling). Main outcomes and measures Estimated percentage of trials for first line advanced NSCLC leading to FDA approval which deviated from NCCN guideline-recommended care with regards to CNS baseline and surveillance imaging. Results A total of 14 studies that had been cited in FDA drug approvals for first line advanced NSCLC met our inclusion criteria between January 1, 2015 and September 30, 2020. Of these trials, 8 (57.1%) deviated from NCCN guidelines in their baseline CNS imaging requirement. The frequency of re-assessment of CNS disease was variable amongst trials as well, with 9 (64.3%) deviating from NCCN recommendations. Conclusions and relevance The trials supporting US FDA drug approvals in first line advanced NSCLC often have CNS imaging requirements that do not adhere to NCCN guidelines. Many trials permit alternative, substandard methods and the proportion of patients undergoing each modality is uniformly not reported. Nonstandard CNS surveillance protocols are common. To best serve patients with advanced NSCLC in the US, drug approvals by the FDA must be based on trials that mirror clinical practice and have imaging requirements consistent with current US standard of care.

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