Atezolizumab 1.875g/15ml solution for injection vials

Atezolizumab has approved indications for the following conditions, with the route of administration being intravenous[L54161] or subcutaneous in combination with [Hyaluronidase (human recombinant)][L52490], in adult patients:

Non-Small Cell Lung Cancer (NSCLC)

- as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumours have PD-L1 expression on ≥ 1% of tumour cells, as determined by an FDA-approved test.
- for the first-line treatment of adult patients with metastatic NSCLC whose tumours have high PD-L1 expression (PD-L1 stained ≥ 50% of tumour cells [TC ≥ 50%] or PD-L1 stained tumour-infiltrating immune cells IC covering ≥ 10% of the tumour area [IC ≥ 10%]), as determined by an FDAapproved test, with no EGFR or ALK genomic tumour aberrations.
- in combination with [bevacizumab], [paclitaxel], and [carboplatin], for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations.
- in combination with paclitaxel protein-bound and carboplatin for the firstline treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
- for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on FDA-approved therapy for NSCLC harbouring these aberrations prior to receiving atezolizumab.

Small Cell Lung Cancer (SCLC)

- in combination with carboplatin and [etoposide], for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
- in combination with [lurbinectedin] for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with atezolizumab (or atezolizumab/hyaluronidase), carboplatin and etoposide.

Hepatocellular Carcinoma (HCC)

- in combination with bevacizumab for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy.

Melanoma

- in combination with [cobimetinib] and [vemurafenib] for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

Atezolizumab has approved indications for the following condition, administered intravenously [L44336], in adult and pediatric patients:

Alveolar Soft Part Sarcoma (ASPS)

- for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic ASPS.
[L44336]


Atezolizumab has an approved indication for the following condition, administered subcutaneously in combination with [Hyaluronidase (human recombinant)] [L52490], in adult patients:

- for the treatment of adult patients with unresectable or metastatic ASPS.
[L52490]