EC Approves Additional Indication for Roche’s Tecentriq in Lung Cancer Treatment

Pharmaceutical Technology Editors

The European Commission has approved an additional indication for Roche’s Tecentriq (atezolizumab) as a first-line monotherapy treatment for metastatic non-small cell lung cancer.

Roche announced on May 5, 2021 that the European Commission (EC) has approved Tecentriq (atezolizumab) as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high programmed death-ligand 1 (PD-L1) expression and have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. The approval makes Tecentriq the first and only single-agent cancer immunotherapy with three dosing options (two weeks, three weeks, or four weeks), allowing for greater flexibility in managing the disease, according to a Roche press release.

Tecentriq has shown clinically meaningful benefit in various types of lung cancer, with five currently approved indications in markets globally. The biologic now has four approved indications in NSCLC in Europe, including as a single agent or in combination with targeted therapies and/or chemotherapies. It was also the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy).

Tecentriq is approved in the United States, European Union (EU), and countries around the world either alone or in combination with targeted therapies and/or chemotherapies in various forms of NSCLC, SCLC, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer, and for hepatocellular carcinoma. In the US, the therapy is also approved in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

“We are delighted to bring Tecentriq to people in the EU with this specific type of lung cancer,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development, in the company press release. “Tecentriq monotherapy has been shown to improve overall survival in people with high PD-L1 expression, when compared to chemotherapy, and therefore represents a new treatment option for people living with this difficult-to-treat disease.”

Source: Roche