Shots:
- FDA has approved Revolution’s Rasonque to treat pts with metastatic pancreatic ductal adenocarcinoma (PDAC) who have received ≥1 prior systemic therapy or who are not candidates for multiagent systemic therapy
- Approval was backed by P-III (RASolute 302) trial assessing Rasonque (300mg, QD, PO) vs CT, in the above-mentioned pts, regardless of RAS mutation, which met all 1 & key 2EPs; data were published in The NEJM
- In the ITT population, Rasonque reduced death risk by 60% vs CT, improving mOS to 13.2 vs 6.7mos & mPFS to 7.2 vs 3.6mos, with consistent RAS G12 results. It also delayed deterioration in global health status (median TTD: 5.7 vs 2.6mos) & pain (median TTD: 9.2 vs 3.8mos)
Ref: Globenewswire | Image: Revolution Medicine | Press Release
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