Cancer drug applications to the EMA and the FDA: A comparison of new drugs and extension of indication in terms of approval decisions and time in review

Allan Cramer; Freja Karuna Hemmingsen Sørup; Hanne Rolighed Christensen; Tonny Studsgaard Petersen; Kristian Karstoft

doi:10.1111/bcp.16391

. 2025 Jan 7;91(5):1431–1438. doi: 10.1111/bcp.16391

Cancer drug applications to the EMA and the FDA: A comparison of new drugs and extension of indication in terms of approval decisions and time in review

Allan Cramer ^1,^✉, Freja Karuna Hemmingsen Sørup ¹, Hanne Rolighed Christensen ¹, Tonny Studsgaard Petersen ^1,², Kristian Karstoft ^1,²

PMCID: PMC12035586 PMID: 39777429

Abstract

Aims

The aim of this study was to compare the final approval decision and time from submission to final decision for new drug applications and applications for extension of indications to the EMA and the FDA within cancer drugs.

Methods

We performed a retrospective analysis on antineoplastic drug applications with a final decision in both the EMA and the FDA from January 1, 2018, to December 31, 2022. For each included drug application, we collected data from the EMA website and the Drugs@FDA database.

Results

A total of 48 new drug applications and 94 applications for extension were included. Agreement in the final decision between the EMA and the FDA was found in 94% of new drug applications and 96% of applications for extension. For new drug applications, the time from submission to approval in the EMA and the FDA were median (interquartile range, IQR) 424 (394–481) days and 216 (169–243) days, respectively. For extensions, the median time from submission to approval in the EMA and the FDA were 295 (245–348) days and 176 (140–183) days, respectively.

Conclusions

We found a high agreement in final approval decisions for cancer drug applications between the EMA and the FDA both for new drug applications and applications for extension. The time from submission to the final decision was markedly shorter in the FDA than in the EMA, albeit the difference was smaller for extensions than for new drug applications. The results indicate that the longer time from submission to decision in the EMA than in the FDA has limited influence on the final approval decisions.

Keywords: application, cancer, drugs, EMA, extensions, FDA, health policy

What is already known about this subject

Applications for extension of indications are currently more frequent than new drug applications within cancer drugs.
There is a notable lack of knowledge of potential differences in the review process of applications for extensions of indications between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

What this study adds

There is a high agreement (>90%) in final decisions within cancer drugs between the EMA and the FDA for new drug applications and for extension of indications.
The time from submission to final decision was markedly shorter in the FDA than in the EMA, albeit the difference was smaller for extensions than for new drug applications.

1. INTRODUCTION

The annual number of drugs approved for various cancer indications has increased in the past decades. ¹ The increase can partly be explained by an increased number of new drug applications and partly by extensions of indications to previously approved cancer drugs, of which the latter now account for most of the applications. ¹ Interestingly, there is a notable lack of knowledge of potential differences in the review process of applications for extensions of indications between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

For new cancer drug applications, it has been reported that they are approved earlier in the United Staes than in the European Union because the FDA receives the drug applications earlier and has shorter review times than the EMA. ² Because many cancers are serious conditions with unmet medical needs, there is a high interest in getting early access to new drugs without compromising the certainty that the drugs have a clinical benefit. The earlier approval by the FDA has raised the question of whether it results in cancer drugs with a questionable risk–benefit balance entering the market. This concern has been emphasized further in recent years due to the many cancer drugs that have been withdrawn in the USA because the required post‐approval trials could not establish the expected clinical benefit. ³ , ⁴ , ⁵ , ⁶ Additionally, examples of discrepancies in the approval decisions of cancer drugs between the EMA and the FDA have been found. ⁴ , ⁷ , ⁸ , ⁹ Divergent decisions between regulatory agencies for a new drug application are of significance because they indicate uncertainty about the risk–benefit balance. It has been reported that the EMA and the FDA overall have a high agreement in decisions of whether new drugs get marketing authorization; the high agreement has also been found specifically within cancer drugs. ⁸ , ¹⁰ However, the agreement in decisions between the EMA and the FDA for applications for extensions of indications has not yet been investigated.

In this study, we aimed to compare the review process in terms of agreement on final approval decision, time of submission, time of approval and review time between the EMA and the FDA for new drug applications and applications for extension of indications within cancer drugs. Awareness of potential discrepancies in the evaluation policies and/or time effectiveness between the two agencies is important as it may highlight parts of the regulatory process that can be optimized for the benefit of the patients and from a socioeconomic perspective.

2. METHODS

We performed a retrospective analysis of cancer drug applications with a final opinion in the EMA and the FDA from January 1, 2018, to December 31, 2022. We identified applications by searching the EMA website for annual reports with opinions from the Committee for Medicinal Products for Human Use (CHMP) on new active substances and extensions of therapeutic indications within the defined time period. ¹¹ We included applications for new active substances (henceforth referred to as “new drug applications”) and applications for extension of therapeutic indications (henceforth referred to as “applications for extension”) if they had an Anatomical Therapeutic Chemical code (ATC code) for antineoplastic agents (L01). ¹² We excluded the applications from the study if the applied treatment indication was not for cancer, if the application was for an advanced therapy medicinal products (ATMPs), ¹³ , ¹⁴ if the FDA had not made a final decision for the same application within the study period, or if the application type to the FDA differed from the application type to EMA (e.g., a new drug application to the EMA but an application for extension to the FDA). To investigate the FDA decisions, we searched the Drugs@FDA database for the same drug indication as the included EMA applications in the study. ¹⁵ Because the FDA does not have a publicly available list of rejected and withdrawn drug applications, we searched press releases from the FDA's official websites, the applicant's official websites, and other relevant media for information about a decision for the given drug indication. If no information about a decision was found, we considered the drug indication as if the FDA was not applied.

For each included drug application, we retrieved data from the European public assessment reports (EPARs) on the EMA website and the FDA reviews in the Drugs@FDA database. Retrieved data were the final decision, for example approval or rejection/withdrawal (subsequent withdrawal of a conditional approval was considered as an approval), type of approval (standard approval or conditional approval (e.g., accelerated approval [AA], conditional marketing authorization [CMA], or marketing authorization under exceptional circumstances), date of the submitted application, and date of final decision. ¹⁵ , ¹⁶

We analysed the included drug applications separately for new drug applications and applications for extension. We reported the agreement in the final decision between the EMA and the FDA as the percentage of drug applications with the same decision in both agencies. We defined the same decision as (1) if both the EMA and the FDA granted standard marketing authorization or CMA/AA/marketing authorization under exceptional circumstances, or (2) if both the EMA and the FDA rejected the application or the applicant withdrew the application. For each of the drug applications with divergent decisions, we described the approval history as well as the possible reason for disagreement. We reported the difference in the date of submission to the EMA and the FDA jointly for approved, rejected and withdrawn applications. In contrast, we reported the time from submission to final decision as well as the difference in the date of the final decision, separately, for the drug applications granted marketing authorization in both agencies and for the drug applications that were rejected or withdrawn. For drug applications approved by the EMA, we considered the final decision date as the date the marketing authorization was issued by the European Commission.

The exclusion of drug applications that did not have a final decision in both the EMA and FDA within the study period could influence the calculated time from submission to decision in the EMA and the FDA. Therefore, we conducted a sensitivity analysis including all drug applications with a final decision in the EMA within the study period and with a final decision in the FDA regardless of the final decision date.

3. RESULTS

We identified 214 new drug applications or applications for extensions with an ATC code for antineoplastic agents, who had a final EMA decision between January 1, 2018, and December 31, 2022. Of those, 72 were excluded resulting in a total of 142 drug applications eligible for analyses (48 new drug applications and 94 applications for extensions; Figure 1).

Flow chart of included drug applications. EMA, European Medicines Agency; FDA, US Food and Drug Administration; ATMPs, advanced therapy medicinal products.

Agreement between final EMA and FDA decisions was found in 94% (45 out of 48) of new drug applications and 96% (90 out of 94) of applications for extensions. In six out of the seven disagreements, the applications were withdrawn or rejected by the EMA, whereas the FDA granted marketing authorization (three standard marketing authorizations and three AA). For the remaining disagreement (cemiplimab), the application to the FDA was withdrawn, whereas the EMA granted marketing authorization. Additional information on the applications with discrepancies in the final decision is provided in Section 3.6.

3.1. Submission of application to the EMA and the FDA

Of the 48 new drug applications, 43 (90%) were submitted to the FDA first, four (8%) were submitted to EMA first, and one (2%) was submitted on the same date. The applications were submitted to the FDA with a median (IQR) of 33 (14–219) days before submission to the EMA (Figure 2). Of the 94 applications for extension, 62 (66%) were submitted to the FDA first, 24 (26%) were submitted to EMA first, six (6%) were submitted on the same date, and for two applications, the submission date to the FDA could not be identified. The applications were submitted to the FDA a median of 12 (−1–53) days before submission to EMA (Figure 2).

Difference in time of submission to EMA and FDA for new drug applications (dark blue box plot) and applications for extension (light blue box plot). The vertical axis is the time difference in days; a positive number indicates that the application has been submitted to the FDA first. “X” represents the mean difference. Values that are significantly higher or lower than most of the values (outliers defined as first quartile − 1.5 * interquartile range or third quartile + 1.5 * interquartile range) in the data are excluded from the boxplot. EMA, European Medicines Agency; FDA, US Food and Drug Administration.

3.2. Approval of new drug applications by the EMA and the FDA

A total of 39 (81%) of the 48 new drug applications were approved by the EMA and the FDA. In the EMA, 19 (49%) were granted standard marketing authorization, 18 (46%) were granted CMA and two (5%) were approved under exceptional circumstances. In the FDA, 16 (41%) were granted standard marketing authorization, and 23 (59%) were granted AA. In the 13 (32%) remaining approvals, there were disagreements between the EMA and the FDA in the type of marketing authorization.

Of the applications for new drug indications that were approved by both the EMA and the FDA, 92% (36 out of 39) were first approved by the FDA. The applications were approved by the FDA a median of 300 (186–545) days before approval by the EMA (Figure 3).

Difference in time of approval by EMA and FDA for new drug applications (dark blue box plot) and applications for extension (light blue box plot). The vertical axis is the time difference in days; a positive number indicates that the FDA approved first. “X” represents the mean difference. Values that are significantly higher or lower than most of the values (outliers defined as first quartile − 1.5 * interquartile range or third quartile + 1.5 * interquartile range) in the data are excluded from the boxplot. EMA, European Medicines Agency; FDA, US Food and Drug Administration.

3.3. Approval of applications for extension by the EMA and the FDA

There were 89 (95%) out of the 94 applications for extension that were approved by both the EMA and the FDA. In the FDA, 80 (85%) were granted standard marketing authorization and nine (15%) were granted AA. In the EMA, CMA cannot be granted to applications for extensions.

Of the applications for extension that were approved by both the EMA and the FDA, 88% (78 out of 89) were first approved by the FDA. The applications were approved by the FDA a median of 154 (89–242) days before approval by the EMA (Figure 3).

3.4. Time from submission to decision

For new drug applications, the time from submission to approval in the EMA and FDA were median 424 (394–481) days and 216 (169–243) days, respectively (Figure 4). The time from submission to approval was a median of 226 (124–279) days shorter in the FDA than in the EMA. For applications for extension, the median time from submission to approval in the EMA and FDA were 295 (245–348) days and 176 (140–183) days, respectively (Figure 4). The time from submission to approval was a median of 135 (65–187) days shorter in the FDA than in the EMA.

Time from submission to approval in EMA and FDA for new drug applications (EMA dark blue box plot, FDA dark green boxplot) and applications for extension (EMA light blue box plot, FDA light green boxplot). The vertical axis is time in days. “X” represents the mean. Values that are significantly higher or lower than most of the values (defined as first quartile − 1.5 * interquartile range or third quartile + 1.5 * interquartile range) in the data are excluded from the boxplot. EMA, European Medicines Agency; FDA, US Food and Drug Administration.

Of the 48 new drug applications to the EMA, nine (19%) marketing authorizations were rejected or the application was withdrawn by the applicant; the median time from submission to rejection/withdrawal was 341 (207–403) days. In the FDA, six (13%) out of the 48 new drug applications were rejected or withdrawn by the applicant; the median time from submission to rejection/withdrawal was 194 (160–213) days.

There were four (4%) out of the 94 applications for extension to the EMA that were withdrawn with a median time from submission to withdrawal of 330 (252–435) days.

3.5. Sensitivity analysis

The sensitivity analysis included all applications with a final opinion in the EMA within the study period and with a final decision in the FDA regardless of the date of the final decision. For new drug applications, five additional drug applications were included in the analysis; the median time from submission of application to decision was 430 days (398–490) in the EMA and 216 days (171–244) in the FDA. For applications for extension, 15 additional drug applications were included in the analysis; the median time from submission of application to decision was 293 days (245–349) in the EMA and 178 days (142–184) in the FDA.

3.6. Divergent decisions in the EMA and the FDA

We found three new drug applications and four applications for extension with discrepancies between the EMA and the FDA in the final decision. In the following section, we briefly describe the regulatory history of these applications. The review of the regulatory history was performed April 13, 2024 and updated November 29, 2024.

Mobocertinib in advanced non‐small cell lung cancer (NSCLC) as second‐line treatment was applied for marketing authorization (new drug application) to the FDA in February 2021; and application to the EMA was 4 months later. The applications were based on a single‐arm study with objective response rate (ORR) as the primary outcome. ¹⁷ In September 2021, the FDA granted AA of mobocertinib based on a response rate of 28% (median duration of response [DOR] of 17.5 months) which was considered reasonably likely to predict a clinical benefit. Additionally, the safety profile was found acceptable for patients with a life‐threatening disease and few other treatment options. For continued approval, the FDA required a randomized clinical trial with progression‐free survival (PFS) as the primary outcome. In July 2022, the applicant withdrew the application for marketing authorization to the EMA after the agency had communicated to the applicant that the data provided were not sufficient to result in a positive opinion. In the EMA assessment report, it was concluded that the risk–benefit balance was considered negative primarily because the clinical benefit could not be established based on a single‐arm trial. In October 2023, the marketing authorization holder announced plans working towards a voluntary withdrawal of mobocertinib because the required post‐approval trials did not meet the primary endpoint. This was effected in July 2024, where the AA was withdrawn from the US market.

Infigratinib in metastatic cholangiocarcinoma as second‐line treatment was applied for marketing authorization (new drug application) to the FDA in September 2020; the application was based on a single‐arm study with ORR as the primary outcome. ¹⁸ In May 2021, the FDA granted AA of infigratinib based on an ORR of 23.1% (median DOR of 5 months), which was considered reasonably likely to predict a clinical benefit and represent a meaningful advantage over existing treatments. Six months later, application for marketing authorization to the EMA was based on the same study. Because of an unconvincing anti‐tumour activity and a severe safety profile the risk–benefit balance was considered negative by the EMA resulting in the withdrawal of the application in October 2022. In November 2022, the marketing authorization holder decided to permanently discontinue the distribution of the drug in the USA because of difficulties in recruiting and enrolling patients in the required confirmatory trial. In May 2024, the AA was withdrawn from the US market.

Ivosidenib in refractory acute myeloid leukaemia with an isocitrate dehydrogenase‐1 mutation was applied for marketing authorization (new drug application) to the FDA in December 2017; the application was based on a single‐arm trial with complete response (CR) as the primary outcome. ¹⁹ In July 2018, the FDA granted standard marketing authorization based on a CR of 33% (DOR 8.2 months), which was considered substantial evidence of effectiveness because it was associated with transfusion independence. In January 2019, application was made to the EMA based on the same trial. The application was withdrawn by the applicant in October 2019, because the risk–benefit balance was considered negative. In the EMA assessment report, the negative opinion was explained by methodology weakness of the single‐arm trial and the need for controlled data. As of April 13, 2024, ivosidenib has standard marketing authorization in the USA.

Cemiplimab in metastatic cervical cancer as second‐line treatment received priority review by the FDA in September 2021; the application for extension was based on an open‐label randomized trial. ²⁰ Six months later, the application was withdrawn. On the applicants' official web pages, it was explained that the reason for withdrawal was that the applicants and the FDA were not able to agree on the post‐marketing studies. No publicly available FDA documents that could support this claim have been identified. In November 2021, application was made to the EMA based on the same study. The study showed an improved overall survival (OS) from cemiplimab compared to chemotherapy (median OS 12.0 vs. 8.5). The improvement in median OS was considered clinically meaningful resulting in the granting of marketing authorization by the EMA for the applied extension of indication. As of April 13, 2024, cemiplimab has a standard marketing authorization in the EU for the given indication.

Application was made to the FDA for pralsetinib in June 2020 for extension to include adult and paediatric patients 12 years of age and older with metastatic RET‐mutant medullary thyroid cancer; the application was based on a single‐arm study with ORR as the primary outcome. ²¹ In December 2020, the FDA granted AA based on an ORR of 66% (84% of the responders having observed a DOR of ≥ 6 months). For continued approval, the FDA required a randomized, open‐label trial comparing pralsetinib to either cabozantinib or vandetanib with PFS as the primary endpoint. In December 2021, application was made to the EMA based on the same trial. Eleven months later, the applicant withdrew the application because the risk–benefit balance was considered negative by the EMA due to a lack of data on patients below 18 years old. In June 2023, the marketing authorization holder announced the voluntary withdrawal of the indication because it was not feasible to conduct the required confirmatory trial. One month later the indication was withdrawn from the market in the United States.

Application was made to the FDA for nivolumab in November 2019 for extension to include treatment of metastatic NSCLC in adults with no EGFR or ALK positive tumour mutations as first‐line treatment in combination with ipilimumab; the application was based on an open‐label, randomized trial comparing nivolumab combined with ipilimumab vs. platinum‐doublet chemotherapy with OS as the primary outcome. ²² In May 2020, the FDA granted standard approval based on OS of 17.1 months in the nivolumab and ipilimumab arm and 14.9 months in the chemotherapy arm, which was a statistically significant difference and considered clinically meaningful. In April 2018, application was made to the EMA for the same extension based on the same trial. In January 2020, the applicant withdrew the application due to a negative opinion from the EMA. The negative opinion was a result of a questioned validity and integrity of the submitted data, and therefore the benefit of the treatment could not be confirmed. As of April 13, 2024, nivolumab has standard marketing authorization in the United States for the given indication.

Application was made to the FDA for pembrolizumab in January 2019 for extension to include metastatic squamous cell carcinoma of the oesophagus with PD‐L1 expression after one or more prior lines of systemic therapy; the application was based on a randomized, open‐label trial comparing pembrolizumab with chemotherapy. ²³ The primary outcome was OS. In July 2019, the FDA granted standard marketing authorization based on a sub‐group analysis showing OS of 9.3 months in the pembrolizumab arm and 6.7 months in the chemotherapy arm, which was statistically significant. In February 2019, application was made to the EMA for the same extension based on the same trial. The application was withdrawn by the applicant in December 2019 because the overall risk–benefit balance was considered negative by the EMA. The reason for the negative opinion was that the subgroup analysis showing improved OS was exploratory and not prespecified. Therefore, it was not considered adequate to confirm the clinical benefit of the treatment. As of April 13, 2024, pembrolizumab has standard marketing authorization in the United States for the given indication.

4. DISCUSSION

In the present study, we found a high agreement in final approval decisions for cancer drugs between the EMA and the FDA; the agreement was 94% for new drug applications and 96% for applications for extension. The applications to the FDA were submitted earlier, had a shorter time from submission to final decision, and were accordingly approved earlier compared to the EMA. The differences were larger for new drug applications than for applications for extension.

This study is the first to compare agreement in final approval decisions between the EMA and the FDA for applications for extension within oncology. A previously published study has shown agreement in final decisions for new drug applications between the EMA and the FDA of more than 90%, across all therapeutic areas and specifically within oncology, which is comparable to our results. ⁸ , ¹⁰ The findings from the present study show that discrepancies between the EMA and the FDA in final approval decisions for antineoplastic drugs are rare both for new drug applications and for applications for extension.

We identified three new drug applications and four applications for extension with discrepancies between the EMA and the FDA in the final decision. In six out of the seven, the FDA granted marketing authorization (three standard marketing authorizations and three AAs), whereas the applications to the EMA were withdrawn or rejected. One of the most common reasons for the negative risk–benefit balance concluded by the EMA was the lack of controlled data due to a single‐arm trial as the pivotal study. Overall, the cases with disagreements between the two agencies indicate that the EMA is more restrictive in granting marketing authorization than the FDA. Supporting this, we found three cases where applications were not approved in the EU, whereas the applications were granted AA in the US and later withdrawn; it should be mentioned that these cases are rare. The discrepancy in approval decisions could be due to differences in the available data during the assessment or differences in the requirements of efficacy and safety between the two agencies.

From 2018 to 2022, new cancer drug applications to the FDA were submitted earlier, had a shorter review time, and were approved earlier than applications to the EMA; the time differences were similar to previously reported data from 2010–2019. ² For applications for extensions, the time differences have not yet been reported in the literature. In the present study, we have shown that applications for extension of indication to the FDA also were submitted earlier, had shorter time from submission to final decision, and were approved earlier than applications to the EMA, albeit the difference was smaller for extension of therapeutic indication than for new drug indications. The earlier submission to the FDA might be motivated by a potentially increased profit for the applicant due to higher drug prices in the United States than in the European Union. ²⁴

The markedly longer time from submission to approval in the EMA than in the FDA has been criticized because the delay potentially could exceed the life expectancy of patients with some types of advanced cancer. ²⁵ The finding from the present study of a high agreement in final decisions between the EMA and the FDA supports this criticism as it indicates that a potentially more thorough evaluation of the drug applications and more available data for the EMA does not affect the final approval decision. However, despite both agencies approving a given application, there might be differences in the type of marketing authorization (e.g., standard marketing authorization, CMA or AA) and differences in the specific indication given (e.g., a different line of treatment or sub‐group of patients), the latter might be a subject for future research. The reason for the longer time from submission to marketing authorization in the EMA than in the FDA and how this can be reduced is also of interest. One explanation that has been proposed in the literature is that the FDA uses expedited programs (e.g., priority review or accelerated assessment) more often than the EMA does. ²⁶ Another explanation is the time from the EMA announcing a positive opinion recommending granting of marketing authorization until the European Commission takes a legally binding decision based on the EMA's recommendation. This decision is issued within 67 days and rarely differs from the EMA opinion. ²⁷ By removing this, the time from submission to marketing authorization in the EU will be reduced; nevertheless, there is still a substantial difference in the review time between the two agencies. Furthermore, there is an additional time gap from approval by the EMA until the drug is accessible in a given EU country.

The knowledge that there is high agreement in decisions between the EMA and the FDA and the later approval in the EU compared with the US (median 300 days later for new cancer drugs and median 154 days later for extensions) can be relevant for national health technology assessment systems (HTAs) in Europe as well as for clinicians because it might help them to better predict when cancer indications likely will get marketing authorization in the EU after approval by the FDA.

The present study has several limitations. First, we used only publicly available data, which implies that drug applications to the EMA and the FDA that were withdrawn or rejected without any published assessment report or press releases were excluded from the study. Second, we excluded drug applications that did not have a final decision in both the EMA and the FDA within the study period. This might influence the results of the time from submission to decision. However, the sensitivity analysis did not change the results markedly, indicating that the potential influence is limited. Third, the study did not include non‐antineoplastic agents that are used to treat cancer such as antihormone therapies. Therefore, we cannot comment on potential discrepancies between the EMA and the FDA in final decisions for these drug applications.

5. CONCLUSION

This study showed a high agreement in final approval decisions for cancer drug applications between the EMA and the FDA; the agreement was 94% for new drug applications and 96% for applications for extension. The median differences in time from submission to decision between the FDA and the EMA for new drug applications and applications for extension were, respectively, 221 and 134 days shorter in the FDA than in the EMA. Furthermore, the applications to the FDA were submitted and approved earlier compared to the EMA; the differences were smaller for applications for extension than for new drug applications. The results indicate that the longer time from submission to decision in the EMA than in the FDA for antineoplastic drug applications has limited influence on the final approval decisions.

AUTHOR CONTRIBUTIONS

A.C. collected and analysed the data. A.C. wrote the first draft of the manuscript, supported by K.K. All authors conceptualized and designed the data collection and analysis, critically revised the manuscript, and approved the final version for submission.

CONFLICT OF INTEREST STATEMENT

The authors declare that they have no competing interests.

Cramer A, Sørup FKH, Christensen HR, Petersen TS, Karstoft K. Cancer drug applications to the EMA and the FDA: A comparison of new drugs and extension of indication in terms of approval decisions and time in review. Br J Clin Pharmacol. 2025;91(5):1431‐1438. doi: 10.1111/bcp.16391

Funding information There was no funding for this study.

DATA AVAILABILITY STATEMENT

All data used in the analyses can be found on the Drugs@FDA database https://www.accessdata.fda.gov/scripts/cder/daf/ and the European Medicines Agency website https://www.ema.europa.eu/en/search/search.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Data Availability Statement

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PERMALINK

Cancer drug applications to the EMA and the FDA: A comparison of new drugs and extension of indication in terms of approval decisions and time in review

Allan Cramer

Freja Karuna Hemmingsen Sørup

Hanne Rolighed Christensen

Tonny Studsgaard Petersen

Kristian Karstoft

Abstract