The U.S. Food and Drug Administration (FDA) deferred action on approving BeiGene (NASDAQ:BGNE) and Novartis' (NYSE:NVS) tislelizumab for esophageal cancer as the agency was unable to carry out required inspections in China due to COVID-19 related travel restrictions.
BeiGene's biologics license application (BLA) was seeking approval of tislelizumab as a second-line (2L) therapy for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC).
The FDA was expected to take a decision by July 12, after accepting the BLA in September 2021.
BeiGene (BGNE) said the FDA was deferring action on the application until the inspections are complete and did not not provide a new expected action date. The BLA remains under review.
"We are working with our partner, Novartis, to facilitate the required inspections and bring tislelizumab to patients with second-line esophageal cancer in the U.S. following regulatory approval," said BeiGene's Co-Founder, Chairman and CEO John Oyler.
The BLA was backed by data from a phase 3 trial called RATIONALE 302.