EMA starts phased review of daraxonrasib for previously-treated metastatic pancreatic cancer
- Sponsor
- Revolution Medicines $RVMD
- Drug
- daraxonrasib
- Indication
- Metastatic pancreatic cancer in patients who have received prior treatment
EMA's Committee for Medicinal Products for Human Use (CHMP) has initiated a phased review of Revolution Medicines' daraxonrasib for the treatment of metastatic pancreatic cancer in patients who have received prior treatment. Phased review is EMA's accelerated-assessment path in which data are evaluated as they become available, compressing overall timeline. The decision was made on the basis of a Phase 3 study published in the New England Journal of Medicine comparing daraxonrasib to chemotherapy, in a patient population with a life expectancy of about 6 months after prior-line progression.
Read original at ema.europa.eu ↗From the source
EMA fast-tracks review of medicine for metastatic pancreatic cancer
EMA's human medicines committee (CHMP) has started a phased review of data on daraxonrasib, a medicine intended for the treatment of metastatic pancreatic cancer. A phased review aims to accelerate the assessment of a medicine by evaluating the data in phases, as they become available.
EMA's decision to start a phased review of daraxonrasib is based on the results of a phase 3 study which compared daraxonrasib with chemotherapy in patients with metastatic pancreatic cancer who had received prior treatment.
People with metastatic pancreatic cancer whose disease progressed after previous treatment have very limited treatment options and a poor prognosis, with a life expectancy of about 6 months. There is therefore a significant unmet medical need for these patients.
Reproduced from EMA News · view original · public domain or open-licensed government work