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The U.S. Food and Drug Administration (FDA) on Wednesday approved Revolution Medicines Inc.'s (NASDAQ:RVMD) Rasonque (daraxonrasib) for metastatic pancreatic adenocarcinoma (PDAC). Specifically, it targets patients who previously underwent at least one systemic therapy or those ineligible for multiagent systemic treatment.
Rasonque marks the first approved targeted cancer therapy from a new class of RAS(ON) multi-selective and mutant-selective inhibitors.
The FDA based its decision on data from the RASolute 302 Phase 3 clinical trial. The global, randomized study pitted Rasonque against investigator-selected cytotoxic chemotherapy in patients battling previously treated metastatic PDAC.
The trial successfully achieved all primary and key secondary endpoints, showing consistent results across the overall intent-to-treat (ITT) group and the specific RAS G12 mutant population.
Within the ITT cohort, Rasonque slashed the risk of death by 60% compared to traditional chemotherapy.
Patients receiving the new targeted therapy achieved a median overall survival of 13.2 months, nearly double the 6.7 months observed with chemotherapy.
Rasonque also significantly improved progression-free survival, recording a median of 7.2 months versus 3.6 months for the chemotherapy control group.
Recognizing the severe symptoms associated with metastatic PDAC, researchers evaluated patient-reported outcomes. Rasonque users experienced a statistically significant delay in the deterioration of overall health and pain levels.
The oral treatment extended the maintenance of quality of life to a median of 5.7 months, compared to 2.6 months for those on chemotherapy.
Rasonque also delayed worsening pain to a median of 9.2 months, vastly outperforming the 3.8 months seen in chemotherapy patients.
RVMD Stock Price Activity: Revolution Medicines shares were up 0.18% at $211.75 at the time of publication on Wednesday, according to market data.
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