INCY - Incyte wins approval of Pemazyre for rare blood cancer
- The US FDA has approved Incyte's ( NASDAQ: INCY ) Pemazyre (pemigatinib) for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.
- The selective fibroblast growth factor receptor (FGFR) inhibitor was approved based on the phase 2 FIGHT-203 study, a single-arm trial in 28 patients.
- Results showed that with patients in the chronic phase in the marrow with or without extramedullary disease, the complete response rate ("CR") was 78%. The median time to response of CR was 104 days.
- Pemazyre gained it first approval in 2020 for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion.
- Seeking Alpha contributor Walter Zelezniak Jr, who has a buy rating on Incyte ( INCY ), provides a technical analysis of the stock .
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Incyte wins approval of Pemazyre for rare blood cancer