RESOLVING THE LEDGER
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SILVER SPRING, Md. \u2014 The U.S. Food and Drug Administration on Wednesday approved Revolution Medicines' targeted drug for adults with \u200bmetastatic pancreatic cancer who have received prior treatment or \u200ccannot receive combination chemotherapy.The drug, branded as Rasonque and also known as daraxonrasib, is a once-daily pill designed to block several forms of the RAS protein, \u200bwhich helps drive tumor growth in many pancreatic cancers.Rasonque, \u200ba first-in-class cancer drug, was included in the FDA Commissioner's National \u2060Priority Voucher program, designed to accelerate reviews from the usual \u200b10 to 12 months to as little as one to two \u200bmonths for therapies that address major U.S. health priorities and substantial unmet medical needs.Given the lack of effective treatment options for pancreatic cancer, the FDA approval \u200bfor Revolution marks a significant advance in a disease area with \u200ba five-year survival rate of about 13%, one of the lowest among major \u200ccancers, \u2060according to the American Cancer Society.The approval was based on a study of 500 adults with previously treated metastatic pancreatic adenocarcinoma, the most common type of pancreatic cancer. The drug improved the \u200brate of overall \u200bsurvival to 13.2 \u2060months, compared with 6.7 months on standard chemotherapy.The FDA had previously granted early access to the drug under a program \u200bwhich allows patients with serious or life threatening conditions \u200bto \u2060receive experimental treatments outside clinical trials prior to authorization by the regulator.The drug's most common side effects included rash, diarrhea, mouth inflammation, nausea, \u2060tiredness, \u200bvomiting, abdominal pain, swelling, reduced appetite and \u200bbleeding.Revolution Medicines did not immediately respond to a Reuters request for comment on pricing \u200band availability.
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