Oct 15 (Reuters) – A European Medicines Agency committee on Thursday recommended EU approval of Revolution Medicines’ 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, was approved in the US in August under an expedited review process for one of the deadliest forms of cancer, and works by blocking RAS proteins that can drive cancer-cell growth.
The committee’s endorsement moves Revolution Medicines’ potential blockbuster closer to launch in Europe, with the European Commission set to make the final call.
Revolution Medicines CEO Mark Goldsmith said in a statement the company looks forward to the European 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, meant 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 for the disease.
The drug drew strong demand in the US after major trial results, prompting the FDA to grant access through its compassionate use program for patients with serious or life-threatening illnesses.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Vijay Kishore)
