- 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.
For further details see:
FDA defers action on Novartis/BeiGene's tislelizumab for esophagus cancer citing inspection woes