Revolution Medines has received FDA approval for Rasonque (daraxonrasib) to treat metastatic pancreatic cancer, marking the first targeted medicine designed to directly inhibit the main cause of the highly aggressive cancer.
Rasonque is an oral therapy for adults with metastatic pancreatic adenocarcinoma who have already received at least one systemic therapy or who are not candidates for multiagent systemic therapy. It is the first RAS(ON) inhibitor (a new class of cancer medicine) to receive approval. The multi-selective, noncovalent, tri-complex inhibitors target cancers caused by a broad range of common RAS genotypes by suppressing RAS signaling.
Approval is based on positive results from the RASolute 302 phase 3 clinical trial. The once-daily tablets reduced the risk of death by 60%, with a median overall survival of 13.2 months compared to 6.7 months with chemotherapy. The drug also improved progression-free survival (PFS), with a median PFS of 7.2 months compared to 3.6 months with chemotherapy, and demonstrated a favorable tolerability profile.