- The Food and Drug Administration, USA, approves Tecentriq as the first immunotherapy for non-small cell lung cancer in the adjuvant setting.
- The approval of Tecentriq was based on the Phase III IMpower010 study that showed an improvement in disease-free survival in comparison with best supportive care.
On October 15, 2021, Genentech announced the approval of Tecentriq (atezolizumab) by the U.S. Food and Drug Administration (FDA) as adjuvant treatment for adult patients diagnosed with Stage II-IIIA non-small cell lung cancer following surgery and platinum-based chemotherapy whose tumors express PD-L1≥1% (as per an FDA-approved diagnostic test).
The approval of Tecentriq was based on the interim analysis of a study namely Phase III IMpower010 study. This demonstrated that patients with Stage II-IIIA non-small cell lung cancer having tumors express PD-L1≥1% who were treated using Tecentriq after surgery and platinum-based chemotherapy significantly decreased the risk of recurrence of the disease or death by approximately 34% with a hazard ratio of 0.66 when compared to best supportive care. Furthermore, there was no identification of new safety signals concerning Tecentriq. 1.8% of patients receiving Tecentriq experienced fatal adverse reactions whereas 18% of the total experienced serious adverse reactions. The most common serious adverse events include pneumonitis, pneumonia, and pyrexia.
Previously, this medicine has demonstrated clinically meaningful benefits concerning the treatment of various lung cancer. In the USA, it has six approved indications. Also, Tecentriq received approval for the front-line treatment of adult patients diagnosed with extensive-stage small-cell lung cancer (SCLC) as cancer immunotherapy in combination with chemotherapy medicines including carboplatin and etoposide.
TECENTRIQ (atezolizumab) belongs to the class of monoclonal antibodies. This medication is designed to bind with a specific protein known as Programmed death-ligand 1 (PD-L1). The drug works to block its interactions with the receptors of both PD-1 and B7.1. It enables the re-activation of T cells in the body by inhibiting PD-L1. However, atezolizumab might also affect normal cells.
View full prescribing information for TECENTRIQ (atezolizumab).