Roche's Tecentriq Gets EC Nod As Adjuvant Treatment For Certain People With Early-stage NSCLC

Roche Holding AG's (RHHBY) blockbuster drug Tecentriq has been approved by the European Commission for yet another lung cancer indication - this time, as an adjuvant treatment for a subset of people with early-stage non-small cell lung cancer.

Today's approval, which marks Tecentriq's sixth lung cancer indication in Europe, is as an adjuvant treatment, following complete resection and platinum-based chemotherapy, for adults with non-small cell lung cancer (NSCLC) with a high risk of recurrence whose tumors express a PD-L1 tumor proportion score of 50% or greater and who do not have EGFR mutant or ALK-positive NSCLC.

Tecentriq has already been approved in 19 countries, including the US and China, as adjuvant treatment, following complete resection and chemotherapy, for adults with Stage II-IIIA NSCLC with PD-L1 tumor proportion score of 1% or greater. In three countries, including Canada and the UK, Tecentriq has been approved as adjuvant, treatment following complete resection and chemotherapy, for adult patients with Stage II-IIIA NSCLC whose tumors have PD-L1 expression on 50% or greater than 50% of tumor cells, according to the company.

"Tecentriq is now the first and only cancer immunotherapy available for the treatment of certain types of early-stage NSCLC," said Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development.

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