BeiGene Receives FDA Approval for TEVIMBRA® for the …
WEBMar 14, 2024 · TEVIMBRA (tislelizumab-jsgr), as a single agent, is indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
WEBThe peak concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of tislelizumab-jsgr increased dose proportionally in the dose range of 0.5 (0.2 times the approved recommended dosage in a 70 kg patient) to 10 mg/kg (3.5 times the approved recommended dosage in a 70 kg patient).
FDA Approves Tevimbra, BeiGene’s Treatment for Adults with …
WEBMar 15, 2024 · Image Credit: Adobe Stock Images/Dr_Microbe. The FDA has approved BeiGene’s Tevimbra (tislelizumab-jsgr) for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors.
TEVIMBRA (tislelizumab-jsgr) granted first FDA approval for …
WEBMarch 18, 2024 by Janice Reichert. On March 13, 2024, the U.S. Food and Drug Administration (FDA) approved TEVIMBRA (tislelizumab-jsgr) 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- …
Tevimbra (tislelizumab-jsgr) FDA Approval History - Drugs.com
WEBMar 25, 2024 · Tevimbra (tislelizumab-jsgr) is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor .
FDA Approves Second-Line Tislelizumab Monotherapy in …
WEBMar 14, 2024 · The FDA has approved tislelizumab-jsgr (Tevimbra) monotherapy for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy not including a PD-L1 inhibitor, according to a press release from BeiGene, the developers of the agent. 1
Tevimbra: Uses, Dosage, Side Effects, Warnings - Drugs.com
WEBMar 13, 2024 · Tevimbra (tislelizumab-jsgr) is a programmed death receptor-1 (PD-1) blocking antibody that is given intravenously (into a vein) and may be used to treat adults with esophageal squamous cell carcinoma that has spread to other parts of the body (metastatic) or cannot be surgically removed.
BeiGene’s Tevimbra receives FDA approval to treat advanced …
WEBMar 18, 2024 · BeiGene’s PD-1 inhibitor Tevimbra (tislelizumab-jsgr) has been approved by the US Food and Drug Administration (FDA) to treat advanced oesophageal squamous cell carcinoma (ESCC). The authorisation specifically applies to adult patients with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
#BeiGene's Tislelizumab Receives Encouraging FDA Approval for ...
WEBMar 16, 2024 · In recent news, BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) announced its successful FDA approval for the use of tislelizumab-jsgr, commercially known as TEVIMBRA, as a treatment option for patients diagnosed with advanced or metastatic esophageal squamous cell carcinoma (ESCC).
FDA Approves Tislelizumab for Unresectable or Metastatic ESCC
WEBMar 14, 2024 · The FDA approved tislelizumab-jsgr (Tevimbra) for treating esophageal squamous cell carcinoma (ESCC) after prior chemotherapy, in patients who haven't received a PD-1/PD-L1 inhibitor. This approval is based on the RATIONALE 302 trial (NCT03430843) that showed tislelizumab improved overall survival compared to chemotherapy for these patients.
Skip to content