EMA’s medicines committee has begun reviewing daraxonrasib in stages, allowing quality, nonclinical and clinical data to be assessed before a full EU marketing application is filed.
Phase 3 results against chemotherapy triggered the move for previously treated metastatic pancreatic cancer, where patients have few options and a life expectancy of about 6 months after progression.
Daraxonrasib was flagged as a high-priority candidate under EMA’s Cancer Medicines Pathfinder, which also sped its eligibility for the EU’s centralized authorization route.
The agency said the phased review should shorten the overall assessment versus a standard process while keeping the same quality, safety and efficacy standards.
EMA plans to use the case as an early model for reformed EU drug rules, potentially extending phased reviews to other high-need, innovative medicines.
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Daraxonrasib’s Breakthrough: EMA Phased Review and Unprecedented Survival Gains in Metastatic Pancreatic Cancer
Overview
The European Medicines Agency (EMA) is fast-tracking the review of daraxonrasib, a high-priority therapy from Revolution Medicines, Inc., using its new phased review process. This approach aims to speed up patient access to innovative treatments by making the evaluation more agile and streamlined. Daraxonrasib’s review is a key example of how the phased review can work in practice, reflecting changes in EU pharmaceutical legislation. The decision to accelerate daraxonrasib’s assessment is based on strong clinical evidence, and highlights the EMA’s commitment to bringing promising therapies to patients sooner.