RE:RE:RE:RE:Market Exclusivity for 'novel' biological drug productsZynyz is a checkpoint inhibitor immunotherapy that targets PD-1. Its approval marks the eight checkpoint inhibitor to hit the market and the third indicated for metastatic MCC, joining Merck & Co.’s PD-1 inhibitor Keytruda and Pfizer and Merck KGaA’s PD-L1 directed Bavencio. The approval was based on data from the POD1UM-201 trial, a single-arm study that tested the drug in adult patients who had not received prior systemic therapy. Zynyz had an objective response rate of 52%. Twelve patients, or 18% of patients, saw a complete response, and 34% (22 patients) achieved partial response. The duration of response in these patients ranged from 1.1 month to more than 24.9 months, with 76% responding for six months or longer and 62% responding for 12 months or longer. In the trial, serious adverse reactions occurred in 22% of patients, with 11% permanently discontinuing treatment due to adverse reactions.
The nod came as a surprise to industry watchers, as the company hadn’t announced its application filing or a decision date.
The analysts see “limited opportunity” for Zynyz given the prevalence of other PD-1 and PD-L1 checkpoint inhibitors. However, an approval for front-line squamous cell anal carcinoma (SCAC) would provide a “niche opportunity” for the company.
MCC is a rare cancer type, affecting less than one per 100,000 people in the U.S..