The approval was based on the P-II (FIGHT-203) study that evaluated Pemazyre (13.5mg, qd in 21-day cycles) in 28 patients aged ≥18yrs. with r/r MLNs with FGFR1 rearrangement
The results showed a CR rate was 78% in patients with chronic phase in marrow with/out EMD; the median time to response was 104 days & median duration of CR was not reached. In patients with blast phase in the marrow with/out EMD & with EMD only, 2 & 1 patients achieved a CR
The complete cytogenetic response rate was 79% in all patients incl. 3 without evidence of morphologic disease. The company provides a patient support program, IncyteCARES which offers access to eligible patients to use Pemazyre incl. financial assistance, ongoing education & additional resources
Ref: Businesswire | Image: Incyte
