Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Diversity
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

BeiGene’s BLA for TEVIMBRA® (tislelizumab) Accepted by FDA for Treatment of First-Line Gastric or Gastroesophageal Junction Cancers

Feb 27, 2024

On 27 February 2024, BeiGene, announced that the U.S. Food and Drug Administration (FDA) accepted BeiGene’s Biologics License Application (BLA) for TEVIMBRA® (tislelizumab), in combination with fluoropyrimidine-and platinum-containing chemotherapy, with a PDUFA date set for December 2024.  The product is intended to offer improved treatment options for patients diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.  

On 19 September 2023, BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following a termination of the previous arrangement between the parties.  Furthermore, BeiGene announced on 26 February 2024, that CHMP issued a positive opinion for its TEVIMBRA® (tislelizumab) to treat NSLC.