Incyte’s Zynyz (retifanlimab-Dlwr) Receives the US FDA’s Approval for Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma
Shots:
- The US FDA has approved Zynyz for adults with metastatic or recurrent LA MCC who had not received prior systemic therapy for their advanced disease
- The approval was based on the (POD1UM-201) trial evaluating Zynyz which showed ORR (52%) in CT-naïve patients, CR (18%), and PR (34%) while DoR ranged from 1.1-24.9+ mos. in the responding patients, 76% experienced a DoR at ≥6mos. and 62% at ≥12mos. by landmark analysis
- Serious AEs in 22% of patients with Zynyz & AEs lead to permanent discontinuation (11%). The company also provides a patient support program i.e., IncyteCARES that offers access to the treatment Zynyz to eligible patients in the US incl. financial assistance, ongoing education & additional resources
Ref: Incyte | Image: Incyte
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