Genentech, Blueprint tout full approval for Gavreto in rare type of lung cancer
Genentech and Blueprint Medicines scored a full FDA approval on Wednesday for Gavreto’s use in a small subset of non-small cell lung cancer patients, nearly three years after celebrating an initial win via the accelerated approval pathway.
Gavreto, also known as pralsetinib, was approved in September 2020 for adults with metastatic NSCLC with RET fusions, which are present in just 1% to 2% of patients, the Roche subsidiary said at the time. Regulators converted the label to a full approval after reviewing supporting data from 123 additional patients over 25 more months of follow-up.
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