WILMINGTON, Del. & PLANEGG, Germany & MUNICH – Incyte (Nasdaq:INCY) and MorphoSys AG (FSE:MOR; NASDAQ:MOR) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy,...
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WILMINGTON, Del. & BOSTON–(BUSINESS WIRE)– Incyte (NASDAQ:INCY) and MorphoSys US Inc., a fully owned subsidiary of MorphoSys AG (FSE: MOR; NASDAQ:MOR), today announced new three-year follow-up data from the ongoing Phase 2 L-MIND study of tafasitamab (Monjuvi®) in combination with lenalidomide in adult patients with relapsed or refractory diffuse large...
WILMINGTON, Del. – Incyte (Nasdaq:INCY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene[1], worsening...
WILMINGTON, Del. — Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Minjuvi® (tafasitamab) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy. “The EC approval of Minjuvi addresses a...
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...
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...