Source: Health Times Sun Huan
As a representative drug of domestic innovative drugs going to sea, the listing application of Xindec Bio's PD-1 antibody sindilizumab in the United States was temporarily frustrated.
On the evening of February 10, the U.S. Food and Drug Administration (FDA) convened the Oncology Drug Advisory Committee (ODAC) to discuss and vote on the new drug application (BLA) of sindilizumab. The BLA declared indications for the first-line treatment of non-squamous non-squamous non-small cell lung cancer (nsqNSCLC) are mainly based on the data of the ORION-11 clinical phase III trial in China.
As a result, the ODAC meeting voted 14-1 to ask Cinda Biologics to supplement additional clinical trials. Innovent Biologics said the committee voted to recommend the need to supplement additional clinical trials before approval to prove the applicability of sindilizumab in the U.S. population and in U.S. medical practice.
Screenshot of Cinda Bio's February 11 announcement
According to public information, Sindili maclizumab is an innovative PD-1 inhibitor jointly developed and commercialized by Innovent Biologics and Eli Lilly Pharmaceuticals. Originally approved by China's State Drug Administration (NMPA) on December 24, 2018, for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma who have at least undergone second-line systemic chemotherapy. Subsequently, non-small cell lung cancer, liver cancer and other indications have been expanded.
In response to the evaluation results of the ODAC meeting, Cinda Biologics said that ORIENT-11 is a high-quality, high-standard, experienced clinical investigators involved in a Chinese clinical trial that meets the requirements of the globally certified GCP. Data from orient-11 trial results show that the combined benefits of sindilizumab outweigh the risks. The FDA does not have any doubts about the safety of sindilizumab.
Although we regret the results of this ODAC vote, Cinda Bio will work with Eli Lilly with FDA to continue to complete the review of the BLA application. This exchange with U.S. regulators will provide valuable experience for Cinda's global pipeline development.
At the same time, Innovent Biotech emphasized that ODAC provides independent professional advice to FDA on oncology drugs that have been listed and are in clinical practice. The FDA will adopt the ODAC vote in the new drug approval process, but the ODAC vote is not binding on FDA's decisions.
