Re:Trial results for new lung cancer drug are 'off the charts'
by ilya_m on Friday May 31, 2024 @07:59PM
(#40541520)
> it is fully approved for ALK+ NSCLC and has been since 2015.
Not exactly. FDA granted it an orphan drug designation in 2014, and then full approval for second- or third-line therapies in 2018 (on the basis of a Phase I/II study). The Phase III study (NCT03052608) is the gift that keeps on giving - it ran 2017-2020, and the progression-free survival in the lorlatinib arm is 60% vs 8% for the control.
Not exactly. FDA granted it an orphan drug designation in 2014, and then full approval for second- or third-line therapies in 2018 (on the basis of a Phase I/II study). The Phase III study (NCT03052608) is the gift that keeps on giving - it ran 2017-2020, and the progression-free survival in the lorlatinib arm is 60% vs 8% for the control.