OBJECTIVES: Cancer types most commonly diagnosed worldwide are lung, colorectal, breast, and prostate cancer. The global expenditure with anticancer drugs and supportive care exceeded US$ 130 billion in 2018. Seventy percent of the new drugs were first approved worldwide by the US Food and Drug Administration (FDA). Horizon scanning (HS) is a tool to identify and antecipate the evaluation of new technologies. This study aimed to analyze the new molecular entity (NME) approved by FDA for lung, breast, prostate, and colorectal cancer approved by FDA from 2016 to 2018. Brazilian regulatory agency (ANVISA) registration were assessed in order to provide brazilian HS candidates.

METHODS: Data were collected on FDA online datase, Drugs@FDA, for NME approved from 2016 to 2018. Regarding those NME, ANVISA registry were checked. Approvals date, generic name, biomarker and FDA special designation for short approval were assessed.

RESULTS: From 2016 to 2018, FDA approved four (50%) NME for breast cancer, three (37.5%) to lung cancer, one (12.5%) to prostate and none to colorectal. Seven (87.5%) used an FDA special designation to fasten review. Two accelerated approval pathway were granted to advanced lung cancer. Seven drugs (87.5%) used a biomarker (i.e.HER-2, HR, ALK, gBRCAm, EGFR). Six drugs (75%) were not approved in Brazil and can be used for potential HS in Brazil: talazoparib, abemaciclib, neratinib, lorlatinib, dacomitinib, brigatinib, and ceritinib. Only two drugs were aproved in Brazil and also on FDA: ribociclib to breast cancer and apalutamide to prostate cancer, the diferences on approval time were respectively 16 and 9 months.

CONCLUSIONS: Biomarker and fast review pathway accounted for 87.5% of the FDA approvals. Six drugs can be used for potential HS in Brazil