The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Roche's Tecentriq (tezolizumab) - a monoclonal antibody designed to bind with a protein called PD-L1 - in combination with Avastin and chemotherapy as an initial treatment for lung cancer.
The treatment is recommended for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC). In people with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with Avastin (bevacizumab), paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.
The decision is based on the multicentre, open-label, randomised, controlled Phase III IMpower150 study which showed that the combination helped people with an advanced form of lung cancer live significantly longer compared with just Avastin and chemotherapy - living an average of 19.8 months compared to 14.9 months.
"We are pleased to receive a positive opinion from the CHMP for this Tecentriq-based combination, which represents a significant step towards bringing a new treatment option to people across Europe with advanced, non-squamous non-small cell lung cancer," said Sandra Horning, MD, Roche's chief medical officer and head of Global Product Development.
She continued: ”The IMpower150 study, on which this opinion is based, demonstrated an overall survival benefit, including those in key populations such as people with EGFR- or ALK-positive mutations or liver metastases."
Lung cancer is the leading cause of cancer death globally and NSCLC is the most prevalent type of lung cancer, accounting for around 85% of all cases.