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EMA Recommends Extension of Therapeutic Indications for Atezolizumab

New indication concerns the adjuvant treatment of patients with early-stage non-small cell lung cancer
24 May 2022
Immunotherapy;  Non-Small Cell Lung Cancer

On 22 April 2022, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product atezolizumab (Tecentriq).

The marketing authorisation holder for this medicinal product is Roche Registration GmbH.

The CHMP adopted a new indication for the treatment of early-stage non-small cell lung cancer (NSCLC).

For information, the full indications for Tecentriq will be as follows (new indication in bold):

Urothelial carcinoma (UC)

Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic UC:

  • after prior platinum-containing chemotherapy, or
  • who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5%. 

Early-stage NSCLC 

Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥50% of tumour cells (TC) and who do not have EGFR mutant or ALK-positive NSCLC. 

Metastatic NSCLC 

  • Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous 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, in combination with nab-paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK-positive NSCLC.
  • Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumours have a PD-L1 expression ≥50% TC or ≥10% tumour infiltrating immune cells and who do not have EGFR mutant or ALK-positive NSCLC.
  • Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK-positive NSCLC should also have received targeted therapies before receiving Tecentriq.

Small cell lung cancer (SCLC)

Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage SCLC.

Triple-negative breast cancer (TNBC)

Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression ≥1% and who have not received prior chemotherapy for metastatic disease.

Hepatocellular carcinoma (HCC)

Tecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable HCC who have not received prior systemic therapy.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

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