FDA approves Rasonque for metastatic pancreatic cancer

The U.S. Food and Drug Administration (FDA) has approved Rasonque (daraxonrasib), a daily oral medication developed by Revolution Medicines for the treatment of adults with metastatic pancreatic adenocarcinoma. The drug is indicated for patients who have previously received systemic therapy or who are not candidates for combination treatments.

Based on the phase 3 RASolute 302 clinical trial involving 500 patients, Rasonque demonstrated significant efficacy by targeting the RAS protein family, which is involved in tumor cell growth. In patients with the RAS G12 mutation, the median overall survival was 13.2 months compared to 6.6 months for those receiving standard chemotherapy. The study reported a 60% reduction in the risk of death and an increase in time to disease progression from 3.5 to 7.3 months.

Additionally, more than 31% of patients using daraxonrasib showed measurable tumor reduction, compared to 11.2% in the chemotherapy group. The medication also showed a favorable safety profile, with only 1.2% of patients discontinuing treatment due to side effects, whereas 11.2% of the chemotherapy group discontinued for the same reason.