LUND, SE / ACCESS Newswire / March 20, 2025 /Alligator Bioscience (Nasdaq Stockholm:ATORX) today announces that the U.S. Food ...

The conversion from accelerated approval to traditional approval was supported by data from the phase 3 KEYNOTE-811 trial.

The FDA has approved Keytruda plus chemotherapy in HER2+ gastric or GEJ adenocarcinoma with PD-L1–positive expression, based on KEYNOTE-811 data.

The FDA granted orphan drug designation to HLX22 for gastric cancer, advancing global phase 3 trials to improve first-line ...

NCT03615326), which included 698 patients with HER2-positive advanced gastric or GEJ adenocarcinoma not previously treated with systemic therapy for metastatic disease; 85% (n=594) of patients had ...

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal ...

et al. Gastric cancer treatment: recent progress and future perspectives. J Hematol Oncol 16, 57 (2023). [6] Jin Li et al., HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive ...

[5] Guan, WL.,et al. Gastric cancer treatment: recent progress and future perspectives. J Hematol Oncol 16, 57 (2023). [6] Jin Li et al., HLX22 plus HLX02 and XELOX for first-line treatment of ...

Gastric cancer is often diagnosed at an advanced stage, with a poor prognosis and a 5-year relative survival rate of only 6%. Despite significant advancements in targeted therapies, such as anti-HER2 ...

Alligator Bioscience (Nasdaq Stockholm: ATORX) today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to HLX22 (AC101) ...

Disitamab vedotin already has a conditional approval in China for HER2-positive gastric cancer, and has been filed for HER2-positive bladder cancer on the strength of a pair of phase 2 trials.