In the wake of recent U.S. FDA pushback on an NDA filing by Innovent Biologics Inc. and Eli Lilly and Co. built around ex-U.S. trial data, few companies are likely to attempt such a feat again soon – at least when the source of the data is China alone.
The Feb. 10 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) is about far more than one biologic license application (BLA), as the single question the agency will put to the committee is whether data from a trial in one foreign country are sufficient to support approval in the U.S.
Following an interim analysis of phase III gastric cancer data, Innovent Biologics Inc. said it’s planning to seek an expanded label the company’s Eli Lilly and Co.-partnered PD-1 inhibitor, Tyvyt (sintilimab), in the indication. According to Innovent, a combination of the drug with chemotherapy met the primary endpoint of overall survival in the study, delivering a statistically significant improvement in the measure vs. placebo, also with chemotherapy.
Following an interim analysis of phase III gastric cancer data, Innovent Biologics Inc. said it’s planning to seek an expanded label the company’s Eli Lilly and Co.-partnered PD-1 inhibitor, Tyvyt (sintilimab), in the indication. According to Innovent, a combination of the drug with chemotherapy met the primary endpoint of overall survival in the study, delivering a statistically significant improvement in the measure vs. placebo, also with chemotherapy.
Innovent Biologics Inc., of Suzhou, has out-licensed ex-China rights for its PD-1 drug Tyvyt (sintilimab) to Eli Lilly and Co. in an expanded license deal. The Chinese firm will receive $200 million upfront in the deal, the value of which could approach up to $1.03 billion. Innovent’s CEO Michael Yu called this “the first solid step in getting Innovent's innovative portfolio into the global market.” With the ex-China rights of Tyvyt, Lilly plans to seek approval for the PD-1 drug in the U.S. and other markets.
Innovent Biologics Inc., of Suzhou, has out-licensed ex-China rights for its PD-1 drug Tyvyt (sintilimab) to Eli Lilly and Co. in an expanded license deal. The Chinese firm will receive $200 million upfront in the deal, the value of which could approach up to $1.03 billion.