Incyte Gets FDA Nod For Hematologic Malignancies Candidate

The U.S. Food and Drug Administration (FDA) has approved Incyte’s INCY Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

The agency reviewed supplemental New Drug Application (sNDA) under Priority Review for Pemazyre in the treatment of adults with relapsed or refractory MLNs with FGFR1 rearrangement.

The regulatory approval was supported by the data readout from the Phase 2 FIGHT-203 study that evaluated the safety and efficacy of Pemazyre in 28 patients with relapsed or refractory MLNs with FGFR1 rearrangement.

The enrolled patients received pemigatinib 13.5 mg once daily in 21-day cycles. Pemigatinib was administered until disease progression or unacceptable toxicity or until patients were able to receive allo-HSCT.

A patient with an MLN with FGFR1 rearrangement may present with bone marrow involvement with a chronic myeloid malignancy.

Hervé Hoppenot, Chief Executive Officer, stated, ”The approval of Pemazyre represents an important treatment advancement for people living with MLNs with FGFR1 rearrangement who currently have limited treatment options. These are complex hematologic malignancies with a range of presentations, and this approval highlights Incyte's continued leadership and commitment to advancing care for patients with rare blood cancers.”

Price Action : Incyte share are trading around 1 percent down at $72.32 on Friday at the time of publication.