A European Medicines Agency committee has recommended EU approval of Revolution Medicines’ (RVMD) drug for adults with metastatic pancreatic cancer, potentially offering patients in the bloc a new option for a disease with limited effective therapies.
The once-daily oral drug Rasonque, chemically known as daraxonrasib, works by blocking RAS proteins that can drive cancer-cell growth. It was approved in the US in August under an expedited review process for one of the deadliest forms of cancer.
The committee’s endorsement moves the potential blockbuster closer to launch in Europe, with the European Commission set to make the final call. Mark Goldsmith, Revolution Medicines’ chief executive, said in a statement that the company looks forward to the Commission’s decision as it continues “to work with regulatory authorities around the world to pursue additional approvals and broaden access to Rasonque.”
The drug, intended for adults whose disease has worsened after prior treatment, is priced at $39,800 in the US for a 30-day supply. Experts have hailed it as a potentially lifesaving treatment, pointing to its efficacy and the prospect of better survival rates for patients with the aggressive cancer.
Pancreatic cancer is often diagnosed after it has spread, with few options once earlier treatment stops working. Chemotherapy remains the primary treatment.
Rasonque drew strong demand in the US after major trial results, prompting the Food and Drug Administration to grant access through its compassionate use program for patients with serious or life-threatening illnesses.