India, Oct. 15 -- Revolution Medicines (RVMD) on Thursday said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for RASONQUE (daraxonrasib) to treat adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy.
The positive opinion is based on the Phase 3 RASolute 302 trial, in which the oral drug reduced the risk of death by 60% compared with chemotherapy in the overall study population. Median overall survival was 13.2 months with RASONQUE, versus 6.7 months with chemotherapy.
The treatment also improved median progression-free survival to 7.2 months, compared with 3.6 months for chemotherapy.
If approved by the Europe...