scholarly journals Cross-comparison of cancer drug approvals at three international regulatory agencies

2016 ◽  
Vol 23 (5) ◽  
pp. 454 ◽  
Author(s):  
N. Samuel ◽  
S. Verma
Keyword(s):  
Antineoplastic Agents ◽  
Drug Product ◽  
Drug Approval ◽  
Primary Objective ◽  
Cancer Drug ◽  
European Medicines Agency ◽  
Cancer Drugs ◽  
Regulatory Bodies ◽  
Drug Approvals ◽  
Health Canada

Background The primary objective of the present study was to examine the drug approval process and the time to approval (tta) for cancer drugs by 3 major international regulatory bodies—Health Canada, the U.S. Food and Drug Administration (fda), and the European Medicines Agency (ema)—and to explore differences in the drug approval processes that might contribute to any disparities.Methods The publicly available Health Canada Drug Product Database was surveyed for all marketed antineoplastic agents approved between 1 January 2005 and 1 June 2013. For the resulting set of cancer drugs, public records of sponsor submission and approval dates by Health Canada, the fda, and the ema were obtained.Results Overall, the tta for the 37 antineoplastic agents that met the study criteria was significantly less for the fda than for the ema (X̄ = 6.7 months, p < 0.001) or for Health Canada (X̄ = 6.4 months, p < 0.001). The tta was not significantly different for Health Canada and the ema (X̄ = 0.65 months, p = 0.89). An analysis of the review processes demonstrated that the primary reason for the identified discrepancies in tta was the disparate use of accelerated approval mechanisms.Summary In the present study, we systematically compared cancer drug approvals at 3 international regulatory bodies. The differences in tta reflect several important considerations in the regulatory framework of cancer drug approvals. Those findings warrant an enhanced dialogue between clinicians and government agencies to understand opportunities and challenges in the current approval processes and to work toward balancing drug safety with timely access

scholarly journals Application of orphan drug designation to cancer treatments (2008–2017): a comprehensive and comparative analysis of the USA and EU

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e028634 ◽  
Author(s):  
Kerstin Noëlle Vokinger ◽  
Aaron S Kesselheim
Keyword(s):  
Orphan Drug ◽  
Drug Product ◽  
Solid Tumours ◽  
Cancer Drug ◽  
European Medicines Agency ◽  
The European Union ◽  
Cancer Drugs ◽  
Orphan Status ◽  
Orphan Designation ◽  
The Usa

ObjectiveTo determine differences in the characteristics of cancer drugs designated as orphan drugs by the Food and Drug Administration (FDA) and European Medicines Agency (EMA).Design and settingIdentification of all cancer drugs (initial or supplementary indication) with orphan status approved by the FDA between 2008–2017 based on publicly accessible reports. The European public assessment reports (EPAR) was searched to determine whether these FDA-approved drugs were also approved by the EMA.Main outcome measuresExtraction of active ingredient, trade name, approval date and approved indication from two FDA data sources (Orphan Drug Product Designation Database, Drugs@FDA) and comparison with the same data from EPAR.ResultsThe FDA approved 135 cancer drugs with orphan indications that met our inclusion criteria, of which 101 (75%) were also approved by the EMA. 80/101 (79%) were first approved in the USA. Only 41/101 (41%) also received orphan designation by the EMA. 33/101 (33%) were approved for biomarker-based indications in the USA, however, only nine approved cancer drug indications by the EMA were biomarker-derived drugs. 78% (47/60) of approved cancer drugs that were only approved in the USA with orphan status were indicated for solid tumours, 22% (13/60) had indications for non-solid tumours. By contrast, out of those approved cancer drugs that received orphan designation by both agencies, 20% (8/41) were indicated for solid, and 80% (33/41) for non-solid tumours.ConclusionsOrphan designation was intended to encourage drug development for rare conditions. This study shows that the FDA approves more cancer drugs with such designations compared with the EMA, especially for subgroups of more prevalent cancers. One reason for the difference could be that the European Union requires demonstration of significant benefit for drugs that target the same indication as a drug already on the market to earn the orphan designation.

scholarly journals Impact of the pan-Canadian Oncology Drug Review on provincial concordance with respect to cancer drug funding decisions and time to funding

2017 ◽  
Vol 24 (5) ◽  
pp. 295 ◽  
Author(s):  
A. Srikanthan ◽  
H. Mai ◽  
N. Penner ◽  
E. Amir ◽  
A. Laupacis ◽  
...  
Keyword(s):  
Linear Models ◽  
Drug Product ◽  
Median Number ◽  
Cancer Drug ◽  
Cancer Drugs ◽  
Oncology Drug ◽  
Before And After ◽  
Canadian Provinces ◽  
The Impact ◽  
Drug Review

Background The pan-Canadian Oncology Drug Review (pcodr) was implemented in 2011 to address uneven drug coverage and lack of transparency with respect to the various provincial cancer drug review processes in Canada. We evaluated the impact of the pcodr on provincial decision concordance and time from Notice of Compliance (noc) to drug funding.Methods In a retrospective review, Health Canada’s Drug Product Database was used to identify new indications for cancer drugs between January 2003 and May 2014, and provincial formulary listings for drug-funding dates and decisions between 1 January 2003 and 31 December 2014 were retrieved. Multiple linear models and quantile regressions were used to evaluate changes in time to decision-making before and after the implementation of the pcodr. Agreement of decisions between provinces was evaluated using kappa statistics.Results Data were available from 9 provinces (all Canadian provinces except Quebec), identifying 88 indications that represented 51 unique cancer drugs. Two provinces lacked available data for all 88 indications at the time of data collection. Interprovincial concordance in drug funding decisions significantly increased after the pcodr’s implementation (Brennan-Prediger coefficient: 0.54 pre-pcodr vs. 0.78 post-pcodr; p = 0.002). Nationwide, the median number of days from Health Canada’s noc date to the date of funding significantly declined (to 393 days from 522 days, p < 0.001). Exploratory analyses excluding provinces with incomplete data did not change the results.Conclusions After the implementation of the pcodr, greater concordance in cancer drug funding decisions between provinces and decreased time to funding decisions were observed.

Surfactant-Based Anhydrous Nano Carrier System for Poorly Aqueous Soluble Anti-Cancer Drugs

2021 ◽  
pp. 413-432
Author(s):  
Shekhar Verma ◽  
Nagendra Chandrawanshi ◽  
Vishal Jain
Keyword(s):  
Controlled Release ◽  
Primary Objective ◽  
Water Soluble ◽  
Cancer Drug ◽  
Cancer Drugs ◽  
Carrier System ◽  
Anti Cancer ◽  
New Chemical Entities ◽  
Poorly Water Soluble ◽  
Nano Emulsion

Around 40% of new chemical entities and drugs are lipophilic or poor aqueous soluble in nature. Among them many anti-cancer drugs are also consist lipophilic properties. Available poorly water soluble anti-cancer drugs are paclitaxel, etoposide, and docetaxel. To get better stability of those anti-cancer drug via encapsulation and searching suitable carrier system for the controlled release, design and development requires of anhydrous nano carrier system. However, to deliver and entrapment of these kind of anti-cancer drugs are very essential with avoidance of water free preparation to get suitable controlled release application and achieve targeting site. The primary objective of proposed chapter is to develop and design novel stable anhydrous or non-aqueous nano emulsion carrier system and provide suitable carrier system for poorly aqueous soluble anti-cancer drugs. Another important aim is to design and develop better stabilizing agent by combining different type of surfactant, co-surfactant, and co-solvent.

Timing of US Food and Drug Administration (FDA) cancer drug approvals relative to publication of clinical trial results.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 2071-2071 ◽  
Author(s):  
Ali Raza Khaki ◽  
Aakash Desai ◽  
Martin W. Schoen ◽  
Bishal Gyawali ◽  
Eddy J. Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cancer Drug ◽  
Cancer Drugs ◽  
Cancer Treatments ◽  
Fda Approval ◽  
Anti Cancer ◽  
Accelerated Approval ◽  
Drug Approvals ◽  
Clinical Trial Results ◽  
Careful Assessment

2071 Background: Publication of clinical trial results in peer reviewed literature is essential to inform clinicians regarding the use of new anti-cancer treatments, which often have a low therapeutic ratio and require careful assessment of risks and benefits. Publication of registration trials should precede FDA approval to facilitate evaluation and implementation of new therapies. The timing of trial publication relative to FDA drug approvals has not been systematically investigated. Methods: We collected all FDA drug approvals for a cancer indication between 2000-19. Trials were identified using FDA labels as well as drugs and publications indexed on HemOnc.org. Approvals for generics/biosimilars, non-oncology indications and label revisions without supportive evidence were excluded. Dates of approval, the approval pathway, approval type (new vs expansion), and the first full publication related to the registration were recorded. Trials and approvals were matched using available metadata. We calculated the proportion of drugs approved prior to publication overall and for those receiving accelerated approval (AA). We used logistic regression to compare rates of pre-publication approval by approval pathway and by new vs expanded approval. Results: Among a total of 378 drug approvals, 139 (37%) had pre-publication approval. Of these, the median overall time from approval to publication was 140 days (IQR 64-281 days). For those with approval after publication, median time from publication to approval was 157 days (IQR 72-359 days). The number of drugs approved pre-publication rose by 27% between the first and last quarters of the study period, though, the proportion decreased as more anti-cancer drugs have been approved in recent years (Table). More drugs were approved pre-publication through AA than regular approval (46% vs 34%, OR 1.66 [95% CI 1.03-2.70], p=0.04) and as new approvals vs. expanded approvals (45% vs 32%, OR 1.76 [95% CI 1.15-2.70], p=0.01). Conclusions: A substantial minority of FDA approvals occur before trial results are published, with the odds being higher for drugs receiving AA and for new approvals. Since clinicians rely upon published results to inform risk/benefit decisions, efforts are needed to ensure trial results are published by the time of FDA approval of new cancer drugs and indications. [Table: see text]

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 Awareness about FDA announcement on voluntary recall of ranitidine among physicians and pharmacists in and around Chennai, India: a cross-sectional study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Rukaiah Fatma Begam ◽  
Yamuna Ravikumar ◽  
Ramaiyan Velmurugan
Keyword(s):  
Healthcare Providers ◽  
Cross Sectional Study ◽  
European Medicines Agency ◽  
Sectional Study ◽  
Cross Sectional ◽  
H2 Blocker ◽  
Voluntary Recall ◽  
Regulatory Bodies ◽  
Study Participants ◽  
Health Canada

Abstract Background Ranitidine is a histamine-2 (H2) blocker, which decreases the amount of acid created by the stomach. In September 2019, the drug was recalled due to impurities N-nitrosodimethylamine (NDMA) by the Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada. NDMA is a carcinogen based on results from laboratory tests. The objective of the study is to assess the awareness among the physicians and pharmacists in and around Chennai about the ranitidine recall notification and its related issues. A descriptive, cross-sectional study was carried out where a questionnaire was administered on 198 physicians and 113 pharmacists who were enrolled in the study. Awareness, knowledge, and issues related to recall notification were recorded from the participants. Results Results showed that only 75% of the study participants were aware of the notification and the issues related, with significantly more participants from the urban area compared with the rural area. When the notification was known by many, the reasons pertaining to the notification were not known. Conclusion Overall, the awareness assessed among physicians and pharmacists was not satisfactory. Physicians and pharmacists are the most responsible healthcare providers and to be updated with every notification on medication published by regulatory bodies.

Female representation in clinical trials leading to FDA cancer drug approvals for gastrointestinal (GI) cancers between 2008 to 2018.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 809-809 ◽  
Author(s):  
Shehara Ramyalini Mendis ◽  
Seerat Anand ◽  
Arvind Dasari ◽  
Joseph M. Unger ◽  
Anirudh Gothwal ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Incidence ◽  
Drug Approval ◽  
Cancer Drug ◽  
Representation Of Women ◽  
Gi Cancer ◽  
Enrollment Rates ◽  
Gi Cancers ◽  
Drug Approvals ◽  
The U.S

809 Background: Proportionate representation of women in health research is an area for improvement. This study aims to assess the representation of women in gastrointestinal (GI) cancer clinical trials leading to FDA cancer drug approvals over the past 10 years. Methods: FDA cancer drug approvals between 07/2008-06/2018 were identified and trial reports supporting approvals sourced. The ratio of female to male (F:M) enrollment was compared with F:M cancer incidence in the U.S., and U.S. cancer prevalence and mortality. Results: Although F:M enrollment for all 229 trials leading to FDA cancer drug approvals in this period was similar to overall F:M cancer incidence in the U.S. (0.89 vs 0.86; Odds Ratio for female enrollment (OR) 1.05, 95% Confidence Interval (CI) 1.03-1.06, P<0.0001), in 17 trials that led to drug approvals in GI cancers there was lower F:M trial enrollment compared to cumulative U.S. incidence at those tumor sites (0.55 vs 0.79, OR 0.71, 95% CI 0.68-0.74, P<0.0001). F:M enrollment and U.S. incidence by the main GI tumor sites where approvals occurred is shown in Table. Female enrollment rates were also lower than U.S. female cancer mortality and prevalence rates in these tumor sites (P<0.0001 for all). Female enrollment in GI trials fell between 2008-2013 and 2014-2018 (38 vs 33%, OR 0.80, 95% CI 0.74-0.87, P<0.0001). Conclusions: Although disparity in female enrollment may be improving across combined FDA cancer drug approval trials, underrepresentation of females has persisted in GI cancer trials when compared to F:M cancer incidence, prevalence and mortality in the U.S. More work is required to determine the drivers of this disparity, in order to mitigate it. [Table: see text]

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