PARAMETER

DATA

Manufacturer

Genentech, Inc.

Indication

Treatment of patients with locally advanced or metastatic urothelial carcinoma who:

• Have disease progression during or following platinum-containing chemotherapy
• Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Cell Substrate

Chinese hamster ovary (CHO) cells

Manufacturing platform

Humanized monoclonal antibody based on an IgG1 (kappa) framework containing humanized heavy chain VHIII and light chain V kappa I subgroup sequences. Atezolizumab is produced using a stably transfected Chinese hamster ovary (CHO) cell line. One of the clones resulting from this transfection was selected as the host cell for production cell-line construction. A two-tier cell banking system of master cell bank and working cell bank was developed and characterized in accordance with ICH guidelines.

Dose in vial/final container

1200 mg/20 mL (60 mg/mL)

Dose to patient

Initial infusion over 60 minutes through an intravenous line with or without a sterile, non-pyrogenic, low-protein binding in-line filter (pore size of 0.2–0.22 micron)

NCT

TITLE

COUNTRIES

NCT01903993

A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared with Docetaxel in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR"

United States, Belgium, Canada, France, Germany, Italy, Korea, Republic of, Poland, Spain, Sweden, Thailand, Turkey, United Kingdom

NCT02031458

A Study of Atezolizumab in Participants with Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

United States, Australia, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, France, Georgia, Germany, Hong Kong, Italy, Japan, Netherlands, Singapore, Slovenia, Spain, Switzerland, Turkey, United Kingdom

NCT01846416

A Study of Atezolizumab in Participants with Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR]

United States, Belgium, France, Netherlands, United Kingdom

NCT01375842

A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PDL1] Antibody) to Evaluate Safety, Tolerability, and Pharmacokinetics in Participants with Locally Advanced or Metastatic Solid Tumors

United States, France, Spain, United Kingdom

NCT02008227

A Study of Atezolizumab Compared with Docetaxel in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy

United States, Argentina, Austria, Brazil, Canada, Chile, Finland, France, Germany, Greece, Guatemala, Hungary, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Norway, Panama, Poland, Portugal,  Russian Federation, Serbia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom

DATE

TYPE OF CHANGE

DESCRIPTION

LINK

03/08/2019

New dosage form

provides for a new 840 mg/14 mL single-dose vial presentation

Approval letter