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  1. FDA approves pembrolizumab for HER2 positive gastric or ...

    Mar 19, 2025 · A statistically significant improvement in OS and PFS was demonstrated in patients randomized to pembrolizumab in combination with trastuzumab and chemotherapy compared with …

  2. KEYNOTE-811: Pembrolizumab Combination in First-Line Setting …

    Oct 25, 2024 · The findings of KEYNOTE-811 further establish pembrolizumab plus chemotherapy as the first-line standard of care in PD-L1–positive advanced HER2-positive gastric or gastroesophageal …

  3. DESTINY-Gastric05 Phase 3 Trial of ENHERTU® Initiated in Patients …

    Mar 31, 2025 · Gastric cancer is associated with a poor prognosis, particularly in advanced stages of the disease where the five-year survival rate is 5% to 10%. 1 Current recommended first-line treatment for …

  4. Cadonilimab (PD-1/CTLA-4) Receives FDA Clearance for Global Phase …

    7 hours ago · In 2024, based on the COMPASSION-15 study results, cadonilimab in combination with chemotherapy was approved in China for the first-line treatment of gastric cancer, demonstrating …

  5. FDA granted traditional approval to pembrolizumab

    Mar 20, 2025 · Clinical Implications These findings transformed first-line therapy for HER2-positive advanced gastric and GEJ adenocarcinomas, leading to the FDA approval of pembrolizumab in …

  6. FDA Grants Standard Approval to Pembrolizumab Plus Trastuzumab/Chemo

    Mar 19, 2025 · The combination of pembrolizumab, trastuzumab, and chemotherapy is now approved in HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma. The FDA granted …

  7. FDA Approves Pembrolizumab/Chemo in First-Line Gastric/GEJ ...

    Mar 19, 2025 · The FDA has approved pembrolizumab (Keytruda) in combination with trastuzumab (Herceptin) and fluoropyrimidine- and platinum-containing chemotherapy in the first-line treatment of …

  8. Breakthroughs in the Systemic Treatment of HER2-Positive Advanced ...

    HER2 = human epidermal growth factor receptor 2. Immune checkpoint inhibitor In cases of advanced or metastatic gastric cancer, and gastroesophageal junction adenocarcinoma with PD-L1 combined …

  9. FDA Approves Pembrolizumab Plus Trastuzumab/Chemo for PD-L1+, …

    Mar 19, 2025 · The combination received accelerated approval from the FDA in May 2021 for use in patients with locally advanced unresectable or metastatic HER2-positive gastric/GEJ cancer …

  10. Pembrolizumab Approved for HER2-Positive Gastric or …

    Mar 20, 2025 · The traditional approval of pembrolizumab in combination with trastuzumab and chemotherapy provides a reliable first-line treatment option for patients with HER2-positive gastric or …