Daraxonrasib approved by FDA for metastatic pancreatic cancer

The FDA has approved daraxonrasib (Rasonque), a new RAS(ON) inhibitor, for treating patients with metastatic pancreatic adenocarcinoma who have undergone prior systemic therapy. The approval follows results from the phase III RASolute 302 clinical study, which involved 500 adult patients.

In the study, patients receiving daraxonrasib showed a median overall survival of 13.2 months, compared to 6.7 months for those receiving standard chemotherapy. The drug demonstrated a significant reduction in the risk of death by approximately 60 percent and nearly doubled the time during which the disease did not progress (7.2 months versus 3.6 months).

Daraxonrasib works by targeting the activated form of the RAS protein, specifically addressing KRAS mutations that drive the growth of pancreatic tumors. While the FDA has granted approval, the European Medicines Agency (EMA) is currently conducting an accelerated assessment of the drug. International guidelines, including those from ESMO, have already begun recommending its use for patients with RAS G12-mutated disease in good functional status.