FDA Grants First Approval to First-Line Therapy for Advanced Anal Cancer

Incyte’s Zynyz receives FDA approval for advanced anal cancer treatment

Incyte's drug Zynyz has become the first treatment specifically approved by the FDA for first-line anal cancer - four years after it was rejected by the regulators. The post Incyte’s Zynyz receives FDA approval for advanced anal cancer treatment appeared first on Delaware Business Times.

Incyte's PD-1 drug brings immunotherapy to anal cancer

Incyte has broken new ground in immuno-oncology, getting FDA approval for its Zynyz drug as a treatment for anal cancer

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

WILMINGTON, Del.--(BUSINESS WIRE)--May 15, 2025-

FDA Grants First Approval to First-Line Therapy for Advanced Anal Cancer

(MedPage Today) -- The FDA granted a first-ever approval for a first-line therapy for anal cancer to the PD-1 inhibitor retifanlimab (Zynyz), the agency announced Thursday. The approval stipulates use in combination with carboplatin and paclitaxel...

FDA Approves First Advanced Anal Cancer Drug as First-Line Treatment

Zynyz is now FDA-approved as the first and only approved first line treatment for advanced squamous cell carcinoma of the anal canal.

Retifanlimab Becomes First FDA-Approved Frontline Treatment for Advanced Anal Cancer

The FDA approved retifanlimab (Zynyz; Incyte) as the first and only first-line treatment for advanced anal cancer, supported by data from the POD1UM-303/InterAACT2 and POD1UM-202 trials.