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FDA Approves Tevimbra Combination for Gastric or Gastroesophageal . . . 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
FDA Approves Tislelizumab-jsgr (Tevimbra) Combo for Gastric or . . . 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 tumors express PD-L1
TEVIMBRA Approved in U. S. for First-line Treatment of Gastric and . . . TEVIMBRA is also approved in the U S as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD- (L)1 inhibitor An additional Biologics License Application (BLA) is under review at the FDA for the first-line treatment of adult patients with locally advanced
FDA Approves Tislelizumab Chemo in Gastric GEJ Adenocarcinoma 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 Received FDA Approval as First-Line Therapy for Gastric and . . . 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
BeiGene’s Tevimbra approved in US for first-line gastric cancer . . . BeiGene has won approval from the US Food and Drug Administration for its PD-1 inhibitor Tevimbra (tislelizumab) in combination with chemotherapy to treat advanced gastric or gastroesophageal junction (G GEJ) adenocarcinoma This approval expands Tevimbra’s indication in the US, where it was previously approved for treating unresectable or metastatic oesophageal squamous cell carcinoma (ESCC
Tevimbra by BeiGene approved in US for initial gastric cancer treatment BeiGene has received approval from the US Food and Drug Administration (FDA) for its PD-1 inhibitor, Tevimbra (tislelizumab), to be used in combination with chemotherapy for the treatment of advanced gastric or gastroesophageal junction (G GEJ) adenocarcinoma
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