Tecentriq (atezolizumab)

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Tecentriq (atezolizumab)

You can order Tecentriq (atezolizumab) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

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 EMA approved (EU); FDA approved (USA); TGA approved (AUS)
CAS Number 1380723-44-3
HS Code 30029090
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 within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy [1] are not eligible for cisplatin chemotherapy [4].
  • metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy [1][5].

Recommended dose

Complete information about atezolizumab dosage and administration can be found here [1][5].
The recommended therapy consists of:
  • 1200 mg as an intravenous infusion over 60 minutes every 3 weeks.
  • Dilute prior to intravenous infusion [1][5].
Consult your treating doctor for personalized dosing.

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 [2]. Atezolizumab is a monoclonal antibody that binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors [1]. By blocking this interaction, checkpoint inhibitors “release the brakes” on the immune system, allowing immune cells to attack tumours [2].

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 [2]. 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 [4].
    • on October 18, 2016, for metastatic non-small cell lung cancer (NSCLC) [3].
  • TGA (Australia)
    • on July 27, 2017, for metastatic non-small cell lung cancer (NSCLC) [5].
  • EMA (EU)
    • on September 22, 2017, for locally advanced or metastatic non-small cell cancer (NSCLC) and metastatic urothelial carcinoma (mUC) on patients who have been previously treated with a platinum-based chemotherapy and as front-line treatment for advanced or metastatic urothelial carcinoma in patients who are not eligible for cisplatin chemotherapy [6].
The efficacy of atezolizumab on urothelial carcinoma 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 [1]. 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 [2].
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 [2].
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 [1][5]. 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 [1][5].
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 [1].
References
[1] Summary of Product Characteristics [FDA]: Tecentriq (atezolizumab), Genentech, Apr. 2017.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761034s001lbl.pdf
[2] NIH. National Cancer Institute. FDA approves new immunotherapy drug for bladder cancer
http://www.cancer.gov/news-events/cancer-currents-blog/2016/fda-atezolizumab-bladder
[3] FDA. Approved Drugs: Atezolizumab (Tecentriq), 18/10/2016.
http://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm525780.htm
[4] Drugs.com. FDA Grants Genentech’s Tecentriq (atezolizumab) Accelerated Approval as Initial Treatment for Certain People with Advanced Bladder Cancer, 17/04/2017.
https://www.drugs.com/newdrugs/fda-grants-genentech-s-tecentriq-atezolizumab-accelerated-approval-initial-certain-advanced-bladder-4518.html
[5] Summary of Product Characteristics [TGA]: Tecentriq (atezolizumab), Roche, Jul. 2017.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2017-PI-02150-1&d=2017091216114622483&d=2017091316114622483
[6] Roche Media Release. Roche receives EU approval of TECENTRIQ® (atezolizumab) in a specific type of metastatic lung cancer and two types of metastatic bladder cancer, 22/09/2017.
https://www.roche.com/media/store/releases/med-cor-2017-09-22c.htm

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.

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