EMA begins phased review of daraxonrasib for metastatic pancreatic cancer treatment
Summary
The European Medicines Agency (EMA) has initiated a phased review of daraxonrasib, a medicine for metastatic pancreatic cancer. This accelerated assessment process evaluates data in phases as it becomes available, based on results from a phase 3 study comparing daraxonrasib with chemotherapy in previously treated patients with metastatic pancreatic cancer. The review aims to address a high unmet medical need for this aggressive cancer.
Source
bskyEMA begins phased review of daraxonrasib for metastatic pancreatic cancer treatmentema.europa.euKey quotes
· 3 pulledEMA'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.
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