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
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
Asciminib significantly improved the Molecular Response Rate at 24 wks vs bosutinib in previously treated CML (Novartis press release)
FDA BTD and NDA filing based on data from ongoing phase 2 VISION study; no PDUFA date mentioned (EMD press release)
The phase 3 IDHENTIFY study failed to show OS benefit with enasidenib compared to standard treatment options in IDH2mut, r/r AML (BMS press release)
The confirmatory CROWN study compared lorlatinib to crizotinib in tx-naïve, ALKpos NSCLC. The study met its’ primary endpoint (PFS by BIRC) at interim analysis. Data has not been presented (Pfizer press release).
Interim analysis of the phase 3 ADAURA study showed a significant improvement in DFS, and study was unblinded early in April 2020 (AZ press release)
