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 (UC) who:
- are considered cisplatin ineligible and whose tumours have a PD-L1 expression greater than or equal to 5%, 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 |
2/2/2024 | Changed Medicine Notification | Data sheet - G2; Data sheet - G3; Administrative fee (CMN) | Granted 4/3/2024 | 28/2/2024 | |
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 |