A new small molecule drug has won approval from the US Food and Drug Administration to treat patients with metastatic pancreatic ductal adenocarcinoma – an aggressive cancer with a poor prognosis for survival. The drug, Rasonque (daraxonrasib), has been authorised for adults who have received at least one prior systemic therapy for their cancer, or who are not candidates for multiagent systemic therapy. Announced on 26 August, the decision was based on the results of a Phase 3 trial involving 500 adults which showed that Rasonque improved median overall survival to 13.2 months compared with 6.7 months for standard chemotherapy.
Metastatic pancreatic ductal adenocarcinoma is the most common type of pancreatic cancer that forms in exocrine cells of the pancreas which make up the glands and ducts that produce enzymes to help with digestion. The abnormal activation of the RAS protein pathway is a key driver of the disease. Rasonque binds to an enzyme that suppresses RAS signalling.
“This drug showed unprecedented results in an area of high unmet need,” Angelo de Claro, head of the FDA’s Oncology Center of Excellence, said in a prepared statement. The approval was granted 6.5 months before the agency’s deadline for user fees. The application was reviewed under the agency’s National Priority Voucher programme which is intended to accelerate the review of therapies that address a major public health need.
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