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Accelerated FDA approval for pralsetinib in RET-fusion positive NSCLC

Approval based on the NSCLC cohorts included in the ARROW phase 1/2 study. Data from thyroid cancer cohorts has been filed; PDUFA in February 2021

Tepotinib granted FDA priority review for METex14 NSCLC

FDA BTD and NDA filing based on data from ongoing phase 2 VISION study; no PDUFA date mentioned (EMD press release)


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