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
Related News:- Incyte Receives EMA’s CHMP Positive Opinion of Opzelura (ruxolitinib) for the Treatment of Non-Segmental Vitiligo
