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Prof. Dr. Mustafa Özdoğan · Medical Oncologist

Atezolizumab receives FDA approval for lung cancer treatment

Atezolizumab receives FDA approval for lung cancer treatment

The immunotherapy drug called Atezolizumab (Tecentriq) received FDA approval on 18 October 2016 for the treatment of stage 4 (metastatic) non-small cell lung cancer.

The results of the clinical studies called OAK and POPLAR brought FDA approval for this new-generation immune therapy.

The OAK study included patients who had previously received lung cancerstandard platinum-based chemotherapy and whose stage 3 or 4 non-small cell lung cancer (NSCLC) had progressed. Some of these patients received the immunotherapy drug Atezolizumab, while the other patients received the chemotherapy drug docetaxel. Atezolizumab increased survival by an average of 4 months compared with docetaxel (13,8 months versus 9,6 months).

PD-L1 is one of the cell surface proteins that suppress the immune system. Atezilozumab is a drug that targets the PD-L1 protein; it binds to PD-L1 and prevents this protein from silencing immune system cells. In this way, it triggers activation of our defense system against cancer.

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The PD-L1 cell surface protein (ligand) is found both on tumors and on some immune system cells (such as dendritic cells). By binding to its specific receptors, such as PD-1 and B7, it switches immune system cells into an inactive state. New-generation immunotherapy drugs such as Atezolizumab block these silencing molecules, triggering activation of the immune system against cancer.

However, when this immunotherapy drug was tested as second-line treatment for lung cancer, it was able to be effective independently of PD-L1 levels, which occur at different densities on tumor cell surfaces and are measured by special pathological immunohistochemical methods. In other words, PD-L1 positivity, which is considered a biological marker for immune therapies, is not a requirement for administering Atezolizumab.

- Related topic: Atezolizumab had previously also received FDA approval for the treatment of bladder cancer.

This drug, which received FDA approval for second-line treatment of NSCLC, has not yet received approval for use in our country. As evidence of its effectiveness increases through clinical studies, it is likely to receive approval for use in our country in the coming period. You can also follow announcements of new cancer drugs approved for use in our country on our website.

Sources

FDA Hematology/Oncology (Cancer) Approvals & Safety Notifications: Atezolizumab (TECENTRIQ)
https://www.fda.gov/ October 18, 2016
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