Revised: 31 May 2019
Medicines
Medsafe Product Detail | ![]() ![]() | |
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File ref: TT50-10037 |
Trade Name | Dose Form | Strength | Identifier |
Tecentriq | Concentrate for infusion | 1200 mg/20mL | |
Sponsor | Application date | Registration situation | Classification |
Roche Products (NZ) Ltd P O Box 109113 Newmarket Auckland 1149 | 20/9/2016 | Consent given Approval date: 14/2/2019 | Prescription |
Composition
Component | Ingredient | Manufacturer |
concentrate for infusion | Active | |
Atezolizumab 1200mg | Roche Diagnostics GmbH Nonnenwald 2 Penzberg 82377 Germany | |
F Hoffmann-La Roche Ltd Grenzacherstrasse 124 Basel CH-4070 Switzerland | ||
Excipient | ||
Glacial acetic acid | ||
Histidine | ||
Polysorbate 20 | ||
Sucrose | ||
Water for injection |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | F Hoffmann-La Roche Ltd Betriebsstandort Analytiklabor Bau 250 Kaiseraugst CH-4303 Switzerland |
Roche Diagnostics GmbH Sandhofer Strasse 116 Mannheim D-68305 Germany | |
Manufacture of Final Dose Form | F Hoffmann-La Roche Ltd Betriebsstandort Kaiseraugst (Parenterals Bau 235) Kaiseraugst CH-4303 Switzerland |
Genentech Inc 4625 NE Brookwood Parkway Hillsboro Oregon 97124-9332 United States of America | |
Roche Diagnostics GmbH Sandhofer Strasse 116 Mannheim D-68305 Germany | |
Packing | F Hoffmann-La Roche Ltd Betriebsstandort Kaiseraugst Kaiseraugst CH-4303 Switzerland |
Genentech Inc 4625 NE Brookwood Parkway Hillsboro Oregon 97124-9332 United States of America | |
Roche Diagnostics GmbH Sandhofer Strasse 116 Mannheim D-68305 Germany | |
Secondary Packaging | F Hoffmann-La Roche Ltd Betriebsstatten Kaiseraugst Wurmisweg Kaiseraugst CH-4303 Switzerland |
NZ Site of Product Release | Roche Products (NZ) Ltd 98 Carlton Gore Road Newmarket Auckland 1023 |
Packaging
Package | Contents | Shelf Life |
Vial, glass, 20 mL with rubber stopper, aluminum seal & flip-off cap in cardboard carton | 1 dose units | 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days diluted stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours diluted stored at or below 25°C |
Indications
Tecentriq as monotherapy is indicated as adjuvant treatment following resection and platinum-based chemotherapy for patients with stage II to IIIA* non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on greater then or equal to 1% of tumour cells (TC).
* According to American Joint Committee on Cancer [7th edition]
Tecentriq, in combination with nab-paclitaxel and carboplatin, is indicated for first-line treatment of patients with metastatic non-squamous NSCLC who do not have tumour EGFR or ALK genomic aberrations.
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy.
Tecentriq, in combination with paclitaxel and carboplatin, is indicated for the first-line treatment of patients with metastatic non-squamous NSCLC who do not have tumour EGFR or ALK genomic aberrations and whose tumours have PD-L1 expression greater than or equal to 1%.
Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of 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.
Tecentriq as monotherapy is indicated for the first-line treatment of adults with metastatic NSCLC whose tumours have high PD-L1 expression (PD-L1 stained greater than or equal to 50% of tumour cells [TC greater than or equal to 50%] or PD-L1 stained tumour-infiltrating immune cells [IC] covering greater than or equal to 10% of the tumour area [IC greater than or equal to 10%]) as determined by a validated test, and who do not have EGFR or ALK genomic tumour aberrations.
TECENTRIQ is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who;
- are considered cisplatin ineligible and whose tumours have a PD-L1 expression greater than or equal to 5%, or who are considered ineligible for any other platinum-containing chemotherapy regardless of level of tumour PD-L1 expression, or
- have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Tecentriq, in combination with nab-paclitaxel, is indicated for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression greater than or equal to 1%, and who have not received prior chemotherapy for metastatic disease.
Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
Tecentriq, in combination with bevacizumab, is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
27/1/2023 | Changed Medicine Notification | Contraindications, warnings and precautions - G1; Administrative fee (CMN) | Granted 2/3/2023 | 31/1/2023 | |
23/2/2018 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances | Granted 14/2/2019 | 27/3/2018 | |
20/9/2016 | Provisional Consent (Section 23) | New medicine - provisional consent | Granted 6/4/2017 | 30/9/2016 | Y |