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 (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 DateApplication TypeChange(s)StatusPayment DatePriority
2/2/2024Changed Medicine NotificationData sheet - G2; Data sheet - G3; Administrative fee (CMN)Granted 4/3/202428/2/2024 
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
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /