Incyte Announces Positive CHMP Opinion for Zynyz® (retifanlimab) for First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC)

Positive CHMP Opinion for Zynyz® (retifanlimab) for First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal ...
Medscape

EU Expands Immunotherapy Indication to Include Anal Cancer

SCAC, while rare, is primarily driven by the human papillomavirus (HPV) and accounts for about 85% of all anal cancers. There ...
Seeking Alpha

Incyte Announces FDA Approval of Zynyz® (retifanlimab-dlwr) Making it the First and Only Approved First-Line Treatment for Advanced Anal Cancer Patients in the United States

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 ...
Rutland Herald

Incyte Japan Announces Approval of Zynyz® (retifanlimab) for the First-Line Treatment of Advanced Anal Cancer

Incyte Biosciences Japan G.K. today announced the Japan Ministry of Health, Labour and Welfare (MHLW) approval of Zynyz ® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based ...
Nasdaq

Incyte : Retifanlimab Plus Chemotherapy Meets Primary Endpoint In Phase 3 SCAC Trial

(RTTNews) - Incyte Corp. (INCY) announced that primary results from the Phase 3 POD1UM-303/InterAACT 2 trial of retifanlimab (Zynyz)—a humanized monoclonal antibody targeting PD-1—combined with ...
Seeking Alpha

Phase 3 Data for Incyte’s Retifanlimab (Zynyz®) in Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) Published in The Lancet

POD1UM-303/InterAACT 2 is the first and largest global Phase 3 trial evaluating a PD-1 inhibitor in combination with chemotherapy for the treatment of patients with advanced SCAC not previously ...
Medscape

Retifanlimab-dlwr Wins Upfront Indication for Anal Cancer

The US Food and Drug Administration has approved two new indications for the PD-1-blocking antibody, retifanlimab-dlwr (Zynyz, Incyte), both for locally recurrent or metastatic squamous cell anal ...
Nasdaq

Knight Therapeutics and Incyte Amend Supply and Distribution Agreement to Add Retifanlimab and Axatilimab in Latin America

MONTREAL, Aug. 04, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that it has expanded its existing ...
ksn.com

MacroGenics Earns $15 Million Milestone Following U.S. FDA Approval of ZYNYZ™ (retifanlimab-dlwr)

ROCKVILLE, MD, March 22, 2023 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the ...
Morningstar

Specialised Therapeutics Expands Partnership with Incyte to Include Two Additional Therapies for Hard-to-Treat Conditions

SINGAPORE, June 12, 2025 /PRNewswire/ -- Independent biopharmaceutical company Specialised Therapeutics (ST) is pleased to announce the expansion of its existing supply and distribution agreement with ...
Eagle-Tribune

Incyte Announces FDA Approval of Zynyz® (retifanlimab-dlwr) Making it the First and Only Approved First-Line Treatment for Advanced Anal Cancer Patients in the United States

Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz ® (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 ...