Background The approval of oncology therapies has increasingly incorporated biomarker-driven precision medicine. However, the influence of mandatory biomarker selection on regulatory pathways remains poorly understood. We compared the regulatory characteristics of targeted and non-targeted oncology therapies first authorised in the European Union between 2015 and 2025. Methods We conducted a retrospective analysis of drug–indication pairs for malignant solid tumours first authorised following EMA assessment and European Commission marketing authorisation between January 2015 and December 2025. Therapies were classified as targeted when mandatory biomarker testing was required for patient selection in the approved indication. Regulatory characteristics and timelines were obtained from publicly available EMA information. The primary regulatory outcome was Conditional Marketing Authorisation (CMA). Results Eighty drug–indication pairs were included: 45 targeted (56.3%) and 35 non-targeted (43.8%). No significant linear temporal trend in the proportion of targeted therapies was detected (OR per year 1.15; 95% CI 1.00–1.33; p = 0.051). CMA was granted to 42.2% of targeted versus 5.7% of non-targeted therapies (OR 12.06; 95% CI 2.57–56.53; p < 0.001). The association remained directionally consistent across sensitivity analyses accounting for calendar year, pharmacological class, tumour type, and multiple indications within the same application. No significant difference in total elapsed time to marketing authorisation was detected (median 419 vs 427 days; median difference − 8days; 95% bootstrap CI −52–21). Conclusions Targeted oncology therapies requiring mandatory biomarker selection were substantially more likely than non-targeted therapies to receive CMA, although the magnitude of the association was imprecisely estimated. Policy summary Greater use of CMA among targeted therapies means that more indications enter the post-authorisation period with confirmatory evidence obligations outstanding. This may be relevant to HTA and reimbursement decisions and warrants longitudinal research on how these obligations and the evidence base evolve after authorisation.
Background and Objectives Geographic inequities in access to cancer care are a determinant of clinical outcomes, yet registry-based evidence from Saudi Arabia remains limited. This retrospective cohort study aimed to examine how geographic location is associated with access to oncology care and cancer outcomes among patients registered at King Fahad Specialist Hospital – Dammam (KFSH-D), a regional tertiary oncology referral centre, in 2023. We compared referral-to-first contact intervals, stage at diagnosis and overall survival between Proximal (≤50 km from KFSH-D) and Distal cities (>50 km). Methods A total of 2042 cancer patients diagnosed between 1 January and 31 December 2023 was identified from KFSH-D Cancer Registry. Patients were divided into three clusters: Proximal cities (n = 1284), Distal cities (n = 683), and outside the Eastern Region (n = 75). Referral-to-first-contact intervals were compared by the Mann–Whitney U test and linear regression. The relationship between geographic position and early stage diagnosis was investigated with binary logistic regression among solid tumour patients (n = 1775). Kaplan–Meier analysis was used to estimate overall survival. Results Patients in a distal city had a significantly longer referral-to-first-contact interval (median 7 days) compared to their proximal counterparts (median 4 days; p < .001). Distal patients had non-significantly higher odds of late-stage diagnosis (early-stage adjusted OR = 0.84, i.e., late-stage OR 1.19; p = .088). Kaplan–Meier analysis revealed a shorter mean survival for non-Eastern Region patients than Proximal (log-rank p = .020); no differences were found for Proximal versus Distal (p = .435). Conclusion Among registered patients, distal residence was associated with longer referral intervals and a non-significant tendency toward late-stage presentation; shorter survival was observed only among out-of-region patients. The findings endorse prioritising pathway streamlining, community-level early detection and GIS-based planning to accomplish the equity objectives of Saudi Arabia’s Health Sector Transformation Program.
