A new tablet-based therapy is drawing attention after regulators reviewed results from patients with advanced disease. Its potential impact could extend beyond one difficult cancer.

The U.S. Food and Drug Administration (FDA) has approved Revolution Medicines’ Rasonque for the treatment of adults with metastatic pancreatic cancer. The therapy is intended for patients who have previously received treatment or are unable to undergo combination chemotherapy.

Rasonque, also known as daraxonrasib, is available as a tablet for daily use. The drug targets several forms of the RAS protein, which plays an important role in tumor development in many cases of pancreatic cancer.

FDA expedited its review of the drug

The FDA included Rasonque in the National Priority Voucher program. It provides for expedited evaluation of therapies that may address important needs of the U.S. healthcare system or are used for diseases with a lack of effective treatment options.

Thanks to this mechanism, the drug review period can be reduced from 10–12 months to one or two months.

Results of the daraxonrasib study

The regulator approved the drug based on a study involving 500 adult patients with previously treated metastatic pancreatic adenocarcinoma. This is the most common type of cancer affecting this organ.

Overall survival among participants receiving Rasonque was 13.2 months. For patients undergoing standard chemotherapy, the figure was 6.7 months.

According to the American Cancer Society, the five-year survival rate for pancreatic cancer is about 13%. This is one of the lowest rates among common cancers.

Before final approval, the FDA had already allowed certain patients to receive daraxonrasib outside clinical trials.

Possible side effects of Rasonque

The most commonly reported adverse reactions during treatment with the drug included:

  • rash and diarrhea;
  • inflammation of the oral mucosa, nausea, and vomiting;
  • fatigue, abdominal pain, and swelling;
  • loss of appetite and bleeding.

Revolution Medicines did not immediately comment on the price of Rasonque or when the drug would become available to patients.