daraxonrasib
Stories
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EMA recommends authorisation of Rasonque for metastatic pancreatic cancer
EMA's CHMP has recommended granting a marketing authorisation for Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior treatment. The recommendation follows a phased review that shortened assessment to less than 150 days, with Rasonque showing a median overall survival of 12.4 months versus 6.7 months for chemotherapy in a phase 3 study of 500 patients.
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CHMP adopts positive opinion on Rasonque for metastatic pancreatic cancer
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 15 October 2026, recommending marketing authorisation for Rasonque, a daraxonrasib monotherapy for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. The product will be available as 100 mg and 150 mg film-coated tablets and is designated as an orphan medicine.