Revolution Medicines, Inc. (NASDAQ:RVMD) received FDA approval for Rasonque, or daraxonrasib, following an expedited review. The once-daily oral RAS inhibitor is approved for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
Revolution Medicines, Inc. (NASDAQ:RVMD) set a wholesale acquisition cost (WAC) of $39,800 for a 30-day supply. Twelve 30-day supplies would total $477,600 at WAC before discounts, rebates, or ******* istance. Rasonque is available in the United States, with (ON)Path offering insurance navigation and financial-assistance resources, including copay support for eligible commercially insured patients.
The approval was based on RASolute 302, a randomized Phase 3 trial involving 500 patients with previously treated metastatic pancreatic adenocarcinoma. In the overall population, median overall survival reached 13.2 months with Rasonque versus 6.7 months with chemotherapy. The hazard ratio of 0.40 represented a 60% lower hazard of death during trial follow-up. Median progression-free survival was 7.2 months versus 3.6 months, while objective response rates were 30% and 11%, respectively.
The survival benefit gives Rasonque a strong clinical argument for reimbursement. Pancreatic cancer is aggressive, treatment options after progression are limited, and Rasonque improved overall survival, progression-free survival, and response rates in a randomized comparison. Oral dosing may also reduce the burden of intravenous chemotherapy.
The approved population is broader than a single mutation-defined subgroup. Rasonque can be prescribed with or without an identified RAS tumor mutation and does not require a companion diagnostic. That reduces testing friction within the approved treatment setting.
#months #pancreatic #progression #medicines
Revolution Medicines, Inc. (NASDAQ:RVMD) set a wholesale acquisition cost (WAC) of $39,800 for a 30-day supply. Twelve 30-day supplies would total $477,600 at WAC before discounts, rebates, or ******* istance. Rasonque is available in the United States, with (ON)Path offering insurance navigation and financial-assistance resources, including copay support for eligible commercially insured patients.
The approval was based on RASolute 302, a randomized Phase 3 trial involving 500 patients with previously treated metastatic pancreatic adenocarcinoma. In the overall population, median overall survival reached 13.2 months with Rasonque versus 6.7 months with chemotherapy. The hazard ratio of 0.40 represented a 60% lower hazard of death during trial follow-up. Median progression-free survival was 7.2 months versus 3.6 months, while objective response rates were 30% and 11%, respectively.
The survival benefit gives Rasonque a strong clinical argument for reimbursement. Pancreatic cancer is aggressive, treatment options after progression are limited, and Rasonque improved overall survival, progression-free survival, and response rates in a randomized comparison. Oral dosing may also reduce the burden of intravenous chemotherapy.
The approved population is broader than a single mutation-defined subgroup. Rasonque can be prescribed with or without an identified RAS tumor mutation and does not require a companion diagnostic. That reduces testing friction within the approved treatment setting.
#months #pancreatic #progression #medicines
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