Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10037
Trade NameDose FormStrengthIdentifier
TecentriqConcentrate for infusion1200 mg/20mL
SponsorApplication dateRegistration situationClassification
Roche Products (NZ) Ltd
P O Box 109113
Newmarket
Auckland 1149
20/9/2016Consent given
Approval date: 14/2/2019
Prescription
 

Composition

ComponentIngredientManufacturer
concentrate for infusionActive 
 Atezolizumab 1200mgRoche 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 stepManufacturer
Finished Product TestingF 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 FormF 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
PackingF 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 PackagingF Hoffmann-La Roche Ltd
Betriebsstatten Kaiseraugst
Wurmisweg
Kaiseraugst CH-4303
Switzerland
NZ Site of Product ReleaseRoche Products (NZ) Ltd
98 Carlton Gore Road
Newmarket
Auckland 1023

Packaging

PackageContentsShelf Life
Vial, glass, 20 mL with rubber stopper, aluminum seal & flip-off cap in cardboard carton1 dose units36 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 DateApplication TypeChange(s)StatusPayment DatePriority
27/1/2023Changed Medicine NotificationContraindications, warnings and precautions - G1; Administrative fee (CMN)Granted 2/3/202331/1/2023 
23/2/2018New Higher-risk Medicine ApplicationNew higher-risk medicine containing one or more new active substancesGranted 14/2/201927/3/2018 
20/9/2016Provisional Consent (Section 23)New medicine - provisional consentGranted 6/4/201730/9/2016Y
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