1556P - Current landscape of drug approvals for genitourinary (GU) cancers in North America and Europe

Background

The landscape of drug approvals for GU cancers varies across countries, with uncertainties prevailing even within high-income countries. We aimed to describe the drug approvals for prostate cancer (PC), renal cell carcinoma (RCC), and urothelial carcinoma (UC) in high-income countries from North America and Europe.

Methods

We searched for all drugs and indications approved for PC, RCC, and UC in the United States (US), Canada (CAN), France (FRA), United Kingdom (UK), Spain (SPA), Italy (ITA), and Portugal (POR) from December 2005 to March 2024. Labels and reports from each country’s drug regulatory agency were reviewed. We collected data on date of approval, trial characteristics, efficacy, toxicity, and quality of life. We calculated the time interval from US approval to approval in each corresponding country (time-to-approval, TTA) for every indication. Substantial clinical benefit (SCB) was determined based on the ESMO-MCBS criteria.

Results

Out of 55 identified approved indications, 20 (36%) were for PC, 20 (36%) for RCC, and 15 (28%) for UC. Of these, only 11 (55%), 8 (40%) and 7 (47%) met the SCB criteria, respectively. The table summarises the number of indications and median TTA per country and cancer type. Countries approving ≥ 75% of total indications for PC included the US, CAN, and FRA; for RCC, it was the US, CAN, FRA, and ITA; and for UC, only the US. Similarly, countries with ≥ 75% approved SCB indications for PC were the US, CAN, FRA, and SPA; for RCC, it was the US, CAN, FRA, and ITA; and for UC, only the US. When compared to the US, countries with TTA < 12 months for PC were CAN, FRA, and SPA; for RCC, it was CAN and FRA; and for UC, only CAN. Table: 1556P

* Described in months.

Conclusions

The US, CAN and FRA led in GU cancers drug approvals, but roughly half of them being SCB. Moreover, CAN and FRA had shorter TTA after the US approval. More heterogeneity was observed in the UK, SPA, ITA, and POR. Finally, UC had fewest indications approved outside the US.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

J.C. Tapia: Other, Conference registration fee, travel, accommodations, and expenses.: Merck, Pfizer, Roche, MSD, EUSA Pharma UK. J. Gavira: Financial Interests, Personal, Speaker’s Bureau: Astellas, LEO Pharma; Non-Financial Interests, Personal, Training: Ipsen, BMS, Novartis, Roche. D. Matthews: Financial Interests, Personal, Invited Speaker: Astellas, Janssen. M. Santoni: Financial Interests, Personal and Institutional, Other, research support and honoraria: Janssen, BMS, Ipsen, Astellas, A.A.A., Bayer. M.N. Young: Financial Interests, Personal, Invited Speaker, Invited speaker to “First Thoughts in renal cell carcinoma” conference in June 2023: Eisai. R. FLIPPOT: Financial Interests, Institutional, Invited Speaker: Ipsen, Pfizer; Financial Interests, Institutional, Advisory Board: MSD (Merck Sharp Dohme), Eisai, Astellas, Bayer, Johnson & Johnson, Merck Serono; Financial Interests, Personal, Other, Travel Expenses: Bristol Myers Squibb; Financial Interests, Institutional, Coordinating PI: Bayer. R. Frazer: Financial Interests, Personal and Institutional, Other, Speaking and/or advisory: BMS; Financial Interests, Other, Speaking and/or advisory: Eisai, Ewopharma, Ipsen, Merck, MSD, Novartis, Pfizer, Pierre Fabre, Recordati, Roche, Sanofi, Sevier. G. Anguera: Financial Interests, Personal, Speaker’s Bureau: Astellas Pharma, BMS, Ipsen, Pfizer; Financial Interests, Personal, Speaker’s Bureau, Travel, accommodation, and expenses.: Merck, Bayer, Janssen. J.P. Maroto Rey: Financial Interests, Personal, Speaker, Consultant, Advisor: Astellas Pharma, Ipsen, BMS, Merck, Bayer, Janssen, Pfizer. All other authors have declared no conflicts of interest.