In a breakthrough development, the US Food and Drug Administration (FDA) has approved Daraxonrasib, the latest targeted treatment for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).
This marks a significant development in the treatment of highly challenging cancers to treat.
Manufactured by Revolution Medicines and marketed as Rasonque, Daraxonrasib’s route of administration is oral, which can only be consumed once per day and targets abnormal RAS signaling, a pathway frequently involved in pancreatic cancer.
The approval is supported by results from the phase 3 RASolute 302 trial, which compared daraxonrasib with doctors’ choice of chemotherapy.
The research revealed that patients receiving daraxonrasib had a median overall survival of 13.2 months, compared with 6.6 months for those receiving chemotherapy.
The treatment significantly minimised the risk of death by 60%, while 53.3% of patients receiving daraxonrasib were still alive after 12 months, compared with 18.7% in the chemotherapy group.
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Daraxonrasib also improved progression-free survival. In patients with RAS G12 mutations, median progression-free survival was 7.3 months with the drug versus 3.5 months with chemotherapy. Tumor response rates were also significantly higher, at 33.2% compared with 11.8%.
Beyond extending survival, the treatment delayed worsening of cancer-related pain and overall quality of life, as per patient-reported outcomes.
Daraxonrasib also showed a favorable safety profile. Multiple treatment-related adverse effects happened in 43.6% of daraxonrasib patients versus 57.5% of those receiving chemotherapy.
FDA officials described the approval as an important new option for people facing an aggressive and historically hard-to-treat disease.
However, the treatment is not a cure, and its long-term benefits and cost will remain important considerations as it enters wider clinical use.
