What Is Atezolizumab (Tecentriq)? FDA Approval, Licensing and Reimbursement in Türkiye

Atezolizumab (Tecentriq): A Decade of PD-L1 Immunotherapy, Approvals in Seven Cancer Types and the Situation in Turkey

Atezolizumab (Tecentriq) is an immunotherapy drug that, among the immune checkpoint inhibitors, targets PD-L1 directly. It started in 2016 with a narrow approval in bladder cancer and is now approved in the US for seven cancer types: two different forms of lung cancer, liver cancer, skin cancer, a soft tissue sarcoma, bladder cancer and colon cancer. Most recently, on October 8, 2026, the FDA approved its use after surgery in stage III colon cancer with mismatch repair deficiency. Along the way, three indications were withdrawn because confirmatory trials did not meet expectations. In this monograph we cover how the drug works, its FDA approval history, the clinical data, its side effects, and its licensing, price and reimbursement status from SGK (the Turkish Social Security Institution) in Turkey. We have covered the colon cancer approval, the subcutaneous form of Tecentriq and SGK conditions for immunotherapy in separate articles.

Fact sheet

What is atezolizumab and how does it work?

Atezolizumab is an immunotherapy drug that binds to the PD-L1 protein on the surface of tumor cells. By blocking PD-L1 from binding to the PD-1 and B7.1 (CD80) receptors on T cells, it releases the "brake" on the immune system, so the patient's own T cells can recognize the tumor and become active against it. It is given intravenously or subcutaneously every 2–4 weeks.

Tumor cells can learn to evade the immune system by displaying large amounts of the PD-L1 protein on their surface. When PD-L1 binds to the PD-1 receptor on T cells, the T cell stops. While pembrolizumab and nivolumab target PD-1, atezolizumab targets PD-L1 directly. It therefore blocks the interaction of PD-L1 with both PD-1 and B7.1, while leaving the PD-L2/PD-1 pathway unaffected (immunotherapies).

• Biomarker: In some indications (for example, lung cancer after surgery and first-line single-agent use in lung cancer), the PD-L1 level in the tumor guides treatment choice; the benefit is clearer in patients with PD-L1 ≥50%.
• Rationale for combinations: Bevacizumab (a drug that blocks the formation of blood vessels) can make the tumor environment more responsive to immunotherapy; this is the scientific basis of the IMbrave150 trial in liver cancer.
• A new approach: With biomarkers such as circulating tumor DNA in the blood (ctDNA) and dMMR, the patients most likely to benefit from treatment can now be selected in the period after surgery.

FDA approval history

The red rows show withdrawn indications. Accelerated approval is based on early but promising data; if the confirmatory phase 3 trial does not show the expected benefit, the approval is withdrawn. Atezolizumab is a good example of a system that both provides fast access and corrects itself (the drug approval process).

Clinical data: key trials

The clinical program of atezolizumab is a rare example that shows both the strength and the limits of immunotherapy. In liver cancer and SCLC it consistently prolonged survival, whereas early signals in breast and bladder cancer could not be confirmed. The two approvals in 2026 show a shift: the drug is no longer given to "everyone", but to the patients selected by biomarkers such as ctDNA or dMMR who benefit the most (ctDNA tests).

Dosage and administration

• The dose is not reduced; in case of side effects, treatment is paused or permanently discontinued.
• For grade 3 immune-related side effects, treatment is usually withheld temporarily; for life-threatening (grade 4) or recurrent serious side effects, it is permanently discontinued.
• If the corticosteroid dose cannot be reduced below the equivalent of 10 mg prednisone daily within 12 weeks, treatment is permanently discontinued.

Pharmacokinetics

• Distribution: The volume of distribution at steady state is about 6.9 L; the antibody stays largely within the blood vessels.
• Metabolism: Like other antibodies, it is broken down into small peptides and amino acids; it is not metabolized by liver enzymes (CYP450).
• Elimination: Clearance is about 0.20 L/day and the half-life about 27 days; steady state is reached in 6–9 weeks.
• Special populations: Age, mild to moderate kidney impairment and mild liver impairment make no clinically meaningful difference.

Drug interactions

Side effects and monitoring

• When used alone: Fatigue/weakness (48%), decreased appetite (25%), nausea (24%), cough (22%) and shortness of breath (22%) are the most common side effects.
• With chemotherapy in lung cancer: Fatigue, nausea, hair loss, constipation, diarrhea and decreased appetite are common.
• With bevacizumab in liver cancer: High blood pressure, fatigue and protein in the urine are the most common side effects.
• With cobimetinib/vemurafenib in melanoma: Rash, muscle and joint pain, fatigue, elevated liver enzymes, fever, itching, swelling, mouth sores, an underactive thyroid gland and sensitivity to sunlight are common.

The key principle of management is to recognize symptoms early and start corticosteroid treatment promptly when needed (how are the side effects of immunotherapy treated?).

Mechanisms of resistance

Several mechanisms have been described in tumors that do not respond to atezolizumab or develop resistance over time: activation of other immune checkpoints such as TIGIT, LAG-3 and TIM-3; an increase in immunosuppressive cells around the tumor (regulatory T cells, myeloid-derived suppressor cells, M2 macrophages); and the release of suppressive molecules such as TGF-β and adenosine. These findings form the basis for studying combinations that target different checkpoints (how do cancer cells develop resistance to treatment?).

License, SGK reimbursement and price in Turkey

The price has risen more than fourfold in nominal terms since 2022, because the prices of imported biotechnological drugs depend on the exchange rate and on periodic pricing decrees. This increase directly affects the cost to the patient for uses that do not meet SGK conditions or that exceed the cycle and duration limits. We covered how long it takes for new drugs to reach Turkey in our access map.

Practical advice for patients and their families

• Who is this drug for? In the lung, liver and bladder cancers for which it is licensed in Turkey, it is used for patients selected according to the type and stage of the disease and test results such as PD-L1.
• How is it given? Into a vein, every 2–4 weeks; the first infusion takes 60 minutes and later ones usually 30 minutes.
• What should I watch for? Tell your care team right away if you develop a new cough, shortness of breath, diarrhea, bloody stools, yellowing of the skin or eyes, extreme fatigue, excessive thirst and frequent urination, headache or a skin rash. These symptoms can appear even months after treatment ends.
• Reimbursement: Clarify from the start, with your care team and your hospital's social services unit, which conditions your medical report needs to meet.
• Options: For indications not licensed in Turkey (new treatments and access in SCLC), clinical trials or importing the drug from abroad can be discussed; if needed, get a second opinion.
• Do not stop or change any medicine you take without talking to your doctor.

Frequently asked questions

Which cancers is atezolizumab (Tecentriq) used for?

In the US, it is approved for non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, BRAF-mutated melanoma, alveolar soft part sarcoma, ctDNA-positive muscle-invasive bladder cancer and stage III dMMR colon cancer. In Turkey, it is licensed for lung cancers, urothelial carcinoma and hepatocellular carcinoma.

Does SGK pay for Tecentriq?

Yes, but only under specific conditions: it is reimbursed with a medical report in non-small cell lung cancer (after surgery, first-line single agent and after chemotherapy), extensive-stage small cell lung cancer and hepatocellular carcinoma. If conditions such as PD-L1 level, the cycle limit and prior immunotherapy are not met, the cost is borne by the patient.

How much does Tecentriq cost?

The price of the 1200 mg/20 mL vial has been 123,966.50 TL since March 31, 2026. The price may change with the exchange rate and pricing decrees.

What are the most important side effects of atezolizumab?

The most common side effects are fatigue, decreased appetite, nausea, cough and shortness of breath. Less common but important ones are inflammation of the lungs, liver, bowel, kidneys and hormone glands, caused by the immune system turning against healthy organs; these need to be recognized and treated early.

Glossary

PD-L1

A protein on the surface of tumor cells that "puts the brakes" on T cells and helps the tumor evade the immune system.

Immune checkpoint inhibitor

A group of drugs that release the brakes of the immune system and strengthen its response against cancer cells.

Accelerated approval

A conditional FDA approval based on early data that must be confirmed by a confirmatory trial.

ctDNA

Circulating tumor DNA in the blood; it can be used to reveal hidden disease remaining after surgery.

dMMR

A tumor type in which the system that repairs DNA copying errors does not work; such tumors are highly sensitive to immunotherapy.

Adjuvant treatment

Preventive treatment given after surgery to reduce the risk of recurrence.

SUT

Health Implementation Communiqué; the regulation that determines which drugs SGK pays for and under which conditions.