Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Mini Oral session: Policy and preventive strategies

1320MO - New oncologic drugs since 2010: Differences in approval and access between the United States, Europe and Brazil


12 Sep 2022


Mini Oral session: Policy and preventive strategies


Global Cancer Statistics;  Cancer Care Equity Principles and Health Economics;  Global Cancer Control;  Therapy

Tumour Site


Rafael Barreto


Annals of Oncology (2022) 33 (suppl_7): S600-S615. 10.1016/annonc/annonc1069


R.B. Barreto, A. Izidoro, A.B.T. Visentainer, R. Mireski

Author affiliations

  • Departamento De Oncologia, CEPON - Centro de Pesquisas Oncológicas, 88034-000 - Florianopolis/BR


This content is available to ESMO members and event participants.

Abstract 1320MO


Progress in cancer treatment happen, partly, as a result of the creation of new anticancer drugs (ACD). New ACDs with novel mechanisms of action were developed by the discovery of new targets or different ways to block them, yet access to these drugs is uneven across different countries. Our objective is to compare the new ACDs approved since 2010 by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Brazilian Health Regulatory Agency (ANVISA).


Data were collected on the FDA, EMA and ANVISA online databases regarding new ACDs approved between January 2010 and May 2022 (date of submission/approval, mechanism of action). Normal distribution was tested by the Shapiro-Wilk test, comparisons were made with the Mann-Whitney test and the data are reported using median days and interquartile range (IQR1-IQR3).


82 new ACDs were approved by FDA from Jan/2010 to May/2022 and 22 (26,8%) were designated as first in class. Checkpoint inhibitors (n=9), anti-HER2/anti-EGFR (n=6 each) and anti-ALK/antiandrogens (n=5 each) were the most approved. EMA approved 74/82 (90,2%) and ANVISA approved 49/82 (59,7%). No new ACD approved by EMA or ANVISA, but not by the FDA was found. Time to approval after submission was 200 days (155-273) at FDA, 359 days (292-416) at EMA and 362 days (264-673) at ANVISA (p<0.00001 for FDA to EMA and FDA to ANVISA). The difference between the submission dates for FDA and EMA was 20 days ([-1]-83). Between FDA and ANVISA the difference was 306 days (134-685). Nineteen (23%) were first submitted at EMA and none at ANVISA. Regarding approval dates for FDA and EMA, the difference was 184 days (60-323) and 9 were approved at EMA before FDA. EMA took 143 days more (84-207) to review the same ADCs. Comparing ANVISA and FDA, approval happened 654 days (402-1098) later and took 174 days (74-411) more. Six were approved at ANVISA before EMA, but none before FDA.


New ACDs are submitted for approval at FDA and EMA at similar dates, but the longer appraisal period by EMA pushes the approval date at Europe to approximately 6 months later. The same steps at ANVISA delay the approval by almost 2 years. Such procedures cause a significant difference in available medications between these regions.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Rafael Barreto.


Has not received any funding.


All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.