Chinese innovative lung cancer drug under review by US FDA

Chinese drugmaker Innovent Biologics, Inc. and the US-based pharmaceutical firm Eli Lilly and Company announced on Tuesday that the US Food and Drug Administration (FDA) accepted for review an application for Sintilimab, an innovative lung cancer drug jointly developed by the two companies.

Liu Yongjun, president of Innovent Biologics, said Sintilimab was the first China-developed innovative drug whose market application has been accepted and entered the formal review stage by the European and U.S. drug regulators. 

“We look forward to working closely with the FDA to potentially bring this sintilimab-pemetrexed-platinum chemotherapy combination as a treatment option in the U.S., following the regimen’s regulatory approval in China earlier this year,” he added.

Innovent Biologics was responsible for the early drug development, and it entered into a collaboration with Eli Lilly in 2015 to co-develop the drug.

The research progress of Sintilimab was published in the journal Lancet Haematology in 2019.

The drug was approved by the National Medical Products Administration to treat relapsed/refractory classical Hodgkin’s lymphoma in December 2018 and gained approval for the first-line treatment of nonsquamous, non-small cell lung cancer in China in February this year.

The FDA granted an Orphan Drug designation to Sintilimab in 2020, for the treatment of esophagus cancer and T-cell lymphoma. In the same year, it was granted the Orphan Drug designation for peripheral T-cell lymphoma by the European Medicines Agency.

“We are pleased the sintilimab submission is progressing. Our pursuit of this proposed indication in the U.S. reinforces Lilly’s and Innovent’s joint commitment to offer additional therapeutic options for people living with lung cancer and the healthcare providers who treat them,” Anne White, president of Lilly Oncology, said in a press release. “This is an encouraging start for our collaborative efforts to make sintilimab available in countries beyond China, as we continue to pursue opportunities globally for this immuno-oncology medicine across various tumor types.”