Shots:
- The US FDA has accepted the NDA for Revolution Medicines’ daraxonrasib to treat pts with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), plus daraxonrasib was selected for the FDA CNPV pilot program
- NDA was backed by P-III (RASolute 302) trial assessing daraxonrasib (300mg, QD, PO) vs CT, in above-mentioned pts, regardless of RAS mutation, which met all 1 & key 2EPs, showing benefits in OS, PFS, cancer-related pain, overall global health status & QoL; data were published in The NEJM
- Additionally, the EMA’s CHMP has initiated a phased review of daraxonrasib, enabling the ongoing assessment of data ahead of a full MAA submission
Ref: Globenewswire | Image: Revolution Medicine | Press Release
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