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FDA Approves Roche's Tecentriq As Adjuvant Treatment For Early Non-small Cell Lung Cancer

The US Food and Drug Administration has approved Roche's (RHHBY) Tecentriq or atezolizumab as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumours express PD-L1=1%, as determined by an FDA-approved test, the company said in a statement.

The approval was based on results from an interim analysis of the Phase III IMpower010 study. The results showed treatment with Tecentriq, following surgery and platinum-based chemotherapy, reduced the risk of disease recurrence or death by 34% in people with Stage II-IIIA NSCLC, compared with best supportive care.

Tecentriq has previously shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications in the US. In addition to becoming the first approved cancer immunotherapy for adjuvant NSCLC, Tecentriq was also the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer in combination with carboplatin and etoposide (chemotherapy).

Tecentriq also has four approved indications in advanced NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks.

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