libre de droit/iStock via Getty Images The U.S. FDA has accepted a resubmission of the Biologics License Application for Astellas Pharma's ( OTCPK:ALPMF ) zolbetuximab for gastric and gastroesophageal junction cancers.
The agency set an action date for the application of Nov. 9. If approved, the monoclonal antibody would become the first claudin 18.
2-targeted treatment for this type of cancer. The BLA is supported by data from two phase 3 trials. The SPOTLIGHT study showed zolbetuximab + chemotherapy reduced the risk of progression or death by 24.
9% compared to chemo alone. The GLOW trial also examined a combination and led to a 31.3% risk reduction compared to chemo alone.
The FDA declined to approve the original zolbetuximab BLA from Astellas ( OTCPK:ALPMY ) in January due to issues with a third-party manufacturer. More on Astellas Pharma Astellas Pharma Inc. (ALPMF) Q4 2023 Earnings Call Transcript Astellas Pharma partners with YASKAWA for innovative cell therapy Astellas Pharma Non-GAAP EPS of ¥84.
19, revenue of ¥1603.67B; initiates FY24 guidance Historical earnings data for Astellas Pharma Dividend scorecard for Astellas Pharma.
