EMA Recommends Extension of Indications for Atezolizumab

New indications concern the first-line treatment of patients with metastatic non-squamous NSCLC who do not have EGFR mutated or ALK positive tumours, and those with extensive-stage SCLC
29 Jul 2019

On 25 July 2019, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending changes 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 new indications as follows (new text in bold):

Urothelial carcinoma

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

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

Non-small cell lung cancer

Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC). In patients with EGFR mutated 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 treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutated or ALK positive NSCLC should also have received targeted therapies before receiving Tecentriq.

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 mutated or ALK positive tumours.

Small cell lung cancer

Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Breast cancer

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

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.

Last update: 29 Jul 2019

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