WILMINGTON, Del. – Incyte (Nasdaq:INCY) announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for treatment of chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. “GVHD is the leading cause of...
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WILMINGTON, Del. – Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for treatment of chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. “GVHD is the leading cause of...
Monjuvi® (tafasitamab-cxix) in combination with rituximab and lenalidomide is the first FDA-approved CD19- and CD20-targeted immunotherapy combination for adult patients with follicular lymphoma (FL) Patients with relapsed or refractory FL achieved significantly improved progression-free survival with Monjuvi in combination with rituximab and lenalidomide in the Phase 3 registration trial This...
Zynyz® (retifanlimab-dlwr), a PD-1 inhibitor, is now approved for the treatment of advanced squamous cell carcinoma of the anal canal (SCAC) in combination with chemotherapy and as a monotherapy Patients with SCAC treated with Zynyz achieved a statistically significant improvement in progression-free survival and improvement in overall survival WILMINGTON, Del....
MONTREAL – Incyte (NASDAQ: INCY) today announced that Health Canada has granted a Notice of Compliance with conditions for Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion...
WILMINGTON, Del. — Incyte (Nasdaq:INCY) today announced new clinical data from two Phase 1 studies evaluating the safety, tolerability and efficacy of INCA033989, a first-in-class mutant calreticulin (mutCALR)-targeted monoclonal antibody, for patients with mutCALR-expressing myeloproliferative neoplasms (MPNs). These preliminary results are from the dose escalation portion of the studies evaluating...
WILMINGTON, Del.- Incyte (Nasdaq:INCY) today announced the outcome of a meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA), which reviewed the Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or...
WILMINGTON, Del. — Incyte (Nasdaq:INCY) today announced new 24-week interim data evaluating the safety and efficacy of povorcitinib (INCB54707), an oral small-molecule highly-selective JAK1 inhibitor, from the pivotal Phase 3 STOP-HS clinical trial program in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS). These data will support...
MORGES, Switzerland — Incyte (Nasdaq:INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Minjuvi® (tafasitamab) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular...
WILMINGTON, Del. – Incyte (Nasdaq:INCY) today announced that positive data from the Phase 3 REACH3 study have been published in The New England Journal of Medicine (NEJM) demonstrating that treatment with ruxolitinib (Jakafi®) resulted in significantly improved outcomes in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GVHD) compared to best available therapy...