Tecentriq FDA approval : Roche subsidiary Genetech has bagged a new approval from the US Food and Drug Administration (FDA) for Tecentriq (atezolizumab), this time in combination with chemotherapy as the first-line treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC).
The chemotherapy to be used for the indication alongside Tecentriq is the combination of carboplatin and etoposide.
Tecentriq FDA approval
Tecentriq is a monoclonal antibody, which has been designed to bind with the PD-L1 protein that is expressed on tumor cells and tumor-infiltrating immune cells. Through the binding, the monoclonal antibody prevents the protein’s interactions with the PD-1 and B7.1 receptors. By blocking PD-L1, Tecentriq may enable reactivation of T cells, which are responsible for a range of immune responses.
The latest Tecentriq FDA approval was driven by the findings of phase 3 IMpower133 trial that demonstrated that the monoclonal antibody in addition with chemotherapy helped people to live longer by a significant extent in comparison to chemotherapy alone in the intention to treat population.
In the late-stage trial that enrolled 403 patients, Tecentriq plus chemotherapy was shown to have significantly decreased the risk of disease worsening or death (progression-free survival, PFS) compared to chemotherapy alone.
Dr. Sandra Horning – Roche Chief Medical Officer and Head of Global Product Development, commenting on the latest Tecentriq FDA approval, said: “Tecentriq is the first cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer, which is especially difficult to treat.
“Until now, there have been limited treatment advances for this disease, and we are excited to bring a potential new standard of care to patients that has been shown to improve survival compared to chemotherapy.”
The FDA had previously approved Tecentriq, in combination with Avastin (bevacizumab) and the chemotherapy combination of paclitaxel and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC without any EGFR or ALK genomic tumor aberrations.
Tecentriq is also approved for metastatic NSCLC in adult patients whose disease progressed during or after treatment with platinum-containing chemotherapy.
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