Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC

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 PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC appeared first on PharmaShots.