Therapeutic value of oncology drugs approved by Health Canada through Project Orbis: a cross-sectional study.

BACKGROUND: In May 2019, the US Food and Drug Administration (FDA) initiated Project Orbis with the aim of providing patients faster access to promising cancer treatments by promoting coordination with international regulatory agencies, including Health Canada. This study evaluates the additional therapeutic value of drugs approved by Health Canada through Project Orbis. METHODS: The FDA list of drugs approved through Project Orbis until the end of 2024 was downloaded and drugs that Health Canada participated in were identified. The type of approval that Health Canada gave these drugs - standard, priority and Notice of Compliance with conditions (NOC/c, conditional approval) was identified. The additional therapeutic value of the drugs (major, moderate and minor) was assessed from the ratings of four international organizations. The distribution of additional therapeutic value (minor, moderate, major) according to review type was compared using a Chi-square test. RESULTS: The FDA approved 68 drugs for 112 indications of which 49 (72.1 %) drugs were reviewed by Health Canada for 78 (69.6 %) indications (30 new drugs and 48 new indications for existing drugs). The manufacturer withdrew one drug from the approval process leaving 77 new drugs and new indications for analysis. Twenty-eight drugs had a standard review, 31 a priority review and 18 a NOC/c review. The distribution of additional therapeutic value by review type was statistically significantly different, p = 0.0052 (Chi-square test). Sixteen (69.6 %) out of 23 drugs with a priority review offered either moderate (10) or major (6) additional therapeutic gains. Only 12 of the remaining 40 drugs with a therapeutic evaluation that had other types of approval had moderate or major additional therapeutic value. CONCLUSION: The results of this study suggest that Health Canada's participation in Project Orbis should concentrate on drugs that qualify for a priority review.