Tecentriq

Tecentriq is given as an infusion (drip) into a vein every 3 weeks and treatment should continue for as long as the patient benefits from it or does not suffer from unmanageable side effects. Treatment may need to be stopped if patients have certain side effects caused by their immune system (the body’s defence system) including inflammation of various body organs or endocrine (glandular) disorders. For more information about using Tecentriq, see the package leaflet or contact your doctor or pharmacist.

Tecentriq can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cancer.

The active substance in Tecentriq, atezolizumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called PD-L1 (programmed death-ligand 1), which is present on many cancer cells.

PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. By attaching to PD-L1 and reducing its effects, Tecentriq increases the ability of the immune system to attack the cancer cells and thereby slow down progression of the disease.

Urothelial cancer

Tecentriq reduces tumours in patients with urothelial cancer that is advanced or has spread. In a study of 429 patients, the cancer shrank or was eliminated after Tecentriq treatment in 23% of patients who were not eligible for platinum chemotherapy and in 16% of patients who had previously had platinum chemotherapy.

In another study involving 931 patients with urothelial cancer, those given Tecentriq lived slightly longer (8.6 months) than patients given chemotherapy (8 months) although the difference could be due to chance. Response was seen even in patients whose cancer cells did not produce much PD-L1.

Non-small cell lung cancer

In patients with non-small cell lung cancer which is advanced or has spread, Tecentriq is more effective than docetaxel (another cancer medicine) at prolonging patients’ lives. In one main study of 850 patients, those given Tecentriq lived for 14 months on average while those given docetaxel lived for 10 months. In a second lung cancer study of 287 patients, patients on Tecentriq lived for 13 months on average compared with 10 months for patients on docetaxel.

In a main study of 1,202 patients with advanced non-small cell lung cancer which has spread and who had not had chemotherapy before, patients given Tecentriq together with paclitaxel, carboplatin and bevacizumab lived on average for 8.4 months without their disease getting worse while those given paclitaxel, carboplatin and bevacizumab lived for on average 6.8 months without their disease getting worse. Overall, patients given Tecentriq with the other medicines lived for 19.8 months on average compared with 14.9 months for patients given the medicines without Tecentriq.

The most common side effects with Tecentriq when used on its own (which may affect more than 1 in 10 people) are tiredness, reduced appetite, nausea (feeling sick), vomiting, cough, difficulty breathing, diarrhoea, rash, fever, joint and back pain, weakness, itching and urinary tract infection. The most common side effects with Tecentriq when used with the cancer medicines paclitaxel, carboplatin and bevacizumab (which may affect more than 2 in 10 people) are peripheral neuropathy (nerve damage in the hands and feet), nausea, anaemia (low red blood cell counts), neutropenia (low white blood cell counts), rash, tiredness, constipation, reduced appetite, diarrhoea, thrombocytopenia (low blood platelet counts) and joint pain.

For the full list of side effects and restrictions, see the package leaflet.

In urothelial cancer, Tecentriq has been shown to reduce tumour size in patients who have been treated with platinum chemotherapy or who are not eligible for such treatment. Tecentriq can also improve survival by several months in patients with non-small cell lung cancer who have few treatment options. Tecentriq’s side effects when used alone are less troublesome than standard chemotherapy treatments. When Tecentriq is used in combination with other cancer medicines, the side effects are more severe but are considered manageable.

The company that markets Tecentriq will put in place an educational program for patients and healthcare professionals to explain that serious immune-related side effects can occur during treatment and what they should do to minimise risks. The company is also carrying out studies to provide more data on the effectiveness of Tecentriq in urothelial cancer and on the medicine’s safety.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tecentriq have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Tecentriq are continuously monitored. Side effects reported with Tecentriq are carefully evaluated and any necessary action taken to protect patients.

Tecentriq received a marketing authorisation valid throughout the EU on 21 September 2017.