Country: European Union
Language: English
Source: EMA (European Medicines Agency)
atezolizumab
Roche Registration GmbH
L01XC32
atezolizumab
Antineoplastic agents
Carcinoma, Transitional Cell; Carcinoma, Non-Small-Cell Lung; Urologic Neoplasms; Breast Neoplasms; Small Cell Lung Carcinoma
Urothelial carcinomaTecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1).Non-small cell lung cancer Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (NSCLC). In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).Tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK positive NSCLC (see section 5.1).Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC (see section 5.1).Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving Tecentriq (see section 5.1).Small cell lung cancerTecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1).Hepatocellular carcinomaTecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy (see section 5.1).Urothelial carcinomaTecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1).Non-small cell lung cancerTecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC (see section 5.1).Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving Tecentriq (see section 5.1).Triple-negative breast cancerTecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.
Revision: 23
Authorised
2017-09-20
151 B. PACKAGE LEAFLET 152 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TECENTRIQ 840 MG CONCENTRATE FOR SOLUTION FOR INFUSION TECENTRIQ 1 200 MG CONCENTRATE FOR SOLUTION FOR INFUSION atezolizumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or nurse. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tecentriq is and what it is used for 2. What you need to know before you are given Tecentriq 3. How Tecentriq is given 4. Possible side effects 5. How to store Tecentriq 6. Contents of the pack and other information 1. WHAT TECENTRIQ IS AND WHAT IT IS USED FOR WHAT TECENTRIQ IS Tecentriq is an anti-cancer medicine that contains the active substance atezolizumab. • It belongs to a group of medicines called monoclonal antibodies. • A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body. • This antibody can help your immune system fight your cancer. WHAT TECENTRIQ IS USED FOR Tecentriq is used in adults to treat: • A kind of bladder cancer, called urothelial carcinoma • A kind of lung cancer, called non-small cell lung cancer • A kind of lung cancer, called small cell lung cancer • A kind of breast cancer, called triple negative breast cancer. • A kind of liver cancer, called hepatocellular carcinoma Patients may get Tecentriq when their cancer has spread to other parts of the body or has come back after previous treatment. Patients may get Tecentriq when their lung cancer has not spread to other parts of the body and treatment will be given after surgery and chemotherapy. Treatment after surgery is called adjuvant therapy. Tecentriq may be given in combination with other anticancer medicines. It is important that you also read the package leaf Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tecentriq 840 mg concentrate for solution for infusion Tecentriq 1 200 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tecentriq 840 mg concentrate for solution for infusion One 14 mL vial of concentrate contains 840 mg of atezolizumab* Tecentriq 1 200 mg concentrate for solution for infusion One 20 mL vial of concentrate contains 1 200 mg atezolizumab* After dilution (see section 6.6) _, _ the final concentration of the diluted solution should be between 3.2 and 16.8 mg/mL _. _ *Atezolizumab is an Fc-engineered, humanised IgG1 anti-programmed death-ligand 1 (PD-L1) monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless to slightly yellowish liquid. The solution has a pH of 5.5 - 6.1 and an osmolality of 129 - 229 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Urothelial carcinoma (UC) Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic UC: • after prior platinum-containing chemotherapy, or • who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1). Early-stage non-small cell lung cancer (NSCLC) Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and who do not have EGFR mutant or ALK -positive NSCLC (see section 5.1 for selection criteria). Metastatic NSCLC Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC. In patients with EGFR mutant or 3 ALK-positive NSCLC, Tecentriq, in combination with bevacizuma Read the complete document