Bridging Gaps in Oncology: Comparative Analysis of Development and Approval Pathways for Anticancer Drugs and Companion Diagnostic in the United States and Japan.

Furthermore, the logistic regression analysis (Table 4 ) indicated that ODD was significantly associated with the likelihood of CDx‐related PMC ( p < 0.042), whereas BTD showed a trend that was not statistically significant ( p = 0.081). 3.4 Gap Between CDx and Drug Approval Dates in Japan and Comparison With the US In Japan, the median approval gap was −18 days (IQR: −52 to 0), indicating that CDx approval generally preceded or occurred simultaneously with drug approval (Figure 3b ).

also in 53,322 other papers