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| Manufacturer || Genentech
| Disease || Lung Cancer / Bladder Cancer
| Indication || Non-Small Cell Lung Cancer (NSCLC); Locally advanced or metastatic urothelial carcinoma
| Mode of Action || PD-L1 blocking antibody (immunotherapy)
| Approval Status || FDA approved (USA); TGA approved (AUS)
| CAS Number || 1380723-44-3
| HS Code || 29331990
| Strength || 60 mg/mL
Who is atezolizumab for?
Atezolizumab is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have either; disease progression during or following platinum-containing chemotherapy; or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy 
. On April 17, 2017, the FDA granted accelerated approval to atezolizumab as front-line treatment for advanced or metastatic urothelial carcinoma in patients who are not eligible for cisplatin chemotherapy 
. Atezolizumab is indicated also for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy 
Complete information about atezolizumab dosage and administration can be found here 
The recommended therapy consists of:
Consult your treating doctor for personalized dosing.
- 1200 mg as an intravenous infusion over 60 minutes every 3 weeks.
- Dilute prior to intravenous infusion .
What is atezolizumab and how does it work?
Atezolizumab belongs to a class of immunotherapy drugs known as checkpoint inhibitors. The drug prevents a protein called PD-L1 that is found on some tumour cells from binding to another protein, PD-1, on immune cells. The binding of these “checkpoint” proteins suppresses the immune response 
. Atezolizumab is a monoclonal antibody that binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors 
. By blocking this interaction, checkpoint inhibitors “release the brakes” on the immune system, allowing immune cells to attack tumours 
What is atezolizumab's approval status?
Atezolizumab was approved by
- FDA (USA)
- on May 18, 2016, for locally advanced or metastatic urothelial carcinoma, with disease progression on or after prior chemotherapy . On April 17, 2017, the FDA extended the approval to the use of atezolizumab as front-line treatment for advanced or metastatic urothelial carcinoma in patients who are not eligible for cisplatin chemotherapy .
- on October 18, 2016, for metastatic non-small cell lung cancer (NSCLC) 
The efficacy of atezolizumab on urothelial carcinoma
- TGA (Australia)
- on July 27, 2017, for metastatic non-small cell lung cancer (NSCLC) .
was investigated in a study that involved 310 patients with locally advanced or metastatic urothelial carcinoma who had disease progression during or following a platinum-containing chemotherapy regimen or who had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen. The median age was 66 years; 78 % were male, 91 % patients were Caucasian. Twenty-six percent had non-bladder urothelial carcinoma and 78% of patients had visceral metastases 
. Approximately 15% of patients had at least a partial shrinkage of their tumours, and this effect lasted from at least 2.1 months to more than 13.8 months. The most common side effects of treatment with atezolizumab were fatigue, decreased appetite, nausea, urinary tract infection, fever, and constipation. The therapy also may cause infection and serious immune system-related side effects 
The FDA also approved a test, called Ventana PD-L1 (SP142), to measure PD-L1 expression on patients’ tumour-infiltrating immune cells. In the trial, increased PD-L1 expression in patients’ tumours was associated with response to atezolizumab. Among the trial participants whose tumours were classified as “positive” for PD-L1 expression, 26 % experienced a tumour response, compared with 9.5 % of the participants whose tumours were “negative” for PD-L1 expression. However, the result of the test should not be considered as binding as patients whose tumours are classified as negative for PD-L1 expression might still respond to the therapy 
.The approval for the treatment of NSCLC
was mainly based on two international, randomized, open-label clinical trials, OAK and POPLAR, that compared atezolizumab to docetaxel, a chemotherapy used to treat different types of cancer.
The main efficacy outcome of the study OAK (GO28915) was the overall survival (OS) in a population of 850 patients. The median OS was 13.8 months (95 % CI: 11.8, 15.7) in the group treated with atezolizumab and 9.6 months (95 % CI: 8.6, 11.2) in the group treated with docetaxel. After 18 months 40 % of the patients treated with atezolizumab were still alive versus 27 % of those treated with docetaxel 
. The main efficacy outcome of the study POLAR (GO28753) was the OS in a population of 287 patients. The median OS was 12.6 months (95 % CI: 9.7, 16.4) in the group treated with atezolizumab and 9.7 months (95% CI: 8.6, 12) in the group treated with docetaxel 
The most common adverse reactions (≥ 20%) in patients with locally advanced or metastatic urothelial carcinoma were fatigue, decreased appetite, nausea, constipation, urinary tract infection, diarrhea, and fever. The most common adverse reactions (≥ 20%) in patients with metastatic non-small cell lung cancer were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation