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

Background

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).

Methods

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).

Results

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.

Conclusions

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.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.