FDA Approves Tevimbra Combination for Gastric or ...
Dec 30, 2024 · A drug called Tevimbra (tislelizumab-jsgr) has been approved for use with chemotherapy as first-line treatment of PD-L1 positive unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Tevimbra was approved earlier in 2024 to treat unresectable or metastatic esophageal squamous cell carcinoma.
TEVIMBRA Approved in U.S. for First-line Treatment of Gastric ...
Dec 27, 2024 · The additional indication for first-line G/GEJ cancers is based on results from BeiGene’s RATIONALE-305 (NCT03777657), a randomized, double-blind, placebo-controlled, global Phase 3 trial to evaluate the efficacy and safety of TEVIMBRA in combination with chemotherapy as a first-line treatment for adult patients with advanced unresectable or metastatic G/GEJ cancer. The study met its primary ...
FDA Approves Tislelizumab Plus Chemo for PD-L1+ Unresectable ...
Dec 27, 2024 · Key Takeaways Tislelizumab-jsgr (Tevimbra) approved for first-line treatment of HER2-negative gastric or GEJ adenocarcinoma with PD-L1 expression. Phase 3 RATIONALE-305 trial showed significant ...
FDA Approves Tislelizumab/Chemo in Gastric/GEJ Adenocarcinoma
Dec 27, 2024 · The FDA previously accepted a biologics license application BLA for tislelizumab plus chemotherapy to treat patients with locally advanced or metastatic gastric or GEJ adenocarcinoma in February 2024. 4 References TEVIMBRA approved in U.S. for first-line treatment of gastric and gastroesophageal junction cancers in combination with chemotherapy.
Tevimbra Plus Chemo May Be Safe, Effective in Advanced ...
Feb 3, 2025 · Frontline treatment with Tevimbra plus irinotecan, paclitaxel, oxaliplatin and 5-FU/leucovorin had promising efficacy and manageable safety in gastric/GEJ cancer. Frontline treatment with Tevimbra plus chemotherapy showed promising efficacy and manageable safety in advanced gastric/GEJ cancer.
FDA Approves Tislelizumab-jsgr as First-Line Therapy for HER2 ...
Jan 2, 2025 · Tislelizumab-jsgr (Tevimbra) was approved in combination with chemotherapy for the treatment of unresectable or metastatic HER2-negative (HER–) gastric or gastroesophageal junction ...
FDA Approves Tislelizumab-jsgr (Tevimbra) Combo for Gastric ...
Dec 30, 2024 · The U.S. Food and Drug Administration approved tislelizumab-jsgr (Tevimbra) in combination with chemotherapy as a first-line treatment for adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinomas whose …
Tislelizumab Scores FDA Approval in Advanced Gastric and GEJ ...
Dec 27, 2024 · Tiselizumab (Tevimbra), an anti–PD-1 monoclonal antibody, plus chemotherapy for the first-line treatment of gastric or gastroesophageal junction (GEJ) cancer has been approved by the FDA. Results from the phase 3 RATIONALE …
Beigene Tevibra Approved in US for Gastric Cancer Treatment
The FDA approved BeiGene's TEVIMBRA (tislelizumab-jsgr), combined with chemotherapy, for first-line treatment of advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults with PD-L1-positive tumors. This approval is based on the positive results from the RATIONALE-305 Phase 3 trial, which showed a significant overall survival benefit for patients receiving ...
TEVIMBRA Received FDA Approval as First-Line Therapy for ...
Dec 28, 2024 · The prognosis for patients with gastric or GEJ cancer depends on the stage at diagnosis, treatment response, and overall health. Immunotherapies, such as TEVIMBRA (tislelizumab), offer a promising approach for first-line treatment in patients with PD-L1 positive advanced or metastatic gastric and GEJ cancers.