ZURICH (Reuters) - Swiss drugmaker Roche Holding AG, seeking to expand uses for its drug Tecentriq beyond bladder cancer, said on Thursday a study had shown the new immunotherapy helped people with lung cancer live longer than with chemotherapy.
The world’s biggest maker of cancer drugs is seeking U.S. Food and Drug Administration approval of Tecentriq for advanced or metastatic non-small cell lung cancer as early as October. It won the regulator’s blessing in May for its use in bladder cancer.
The FDA has already granted the medicine accelerated review.
Winning broad approval for Tecentriq, designed to help the immune system fight tumors that otherwise evade detection, is central to Roche’s strategy of developing new drugs as patent expirations leave its older medicines vulnerable to cheaper biosimilars starting in 2017.
“These results add to the growing body of evidence that supports the role of Tecentriq as a potential new treatment for specific types of advanced non-small cell lung cancer,” Chief Medical Officer Sandra Horning said of the results of the Phase III study.
Analysts estimate Tecentriq sales could top 2.8 billion Swiss francs ($2.84 billion) by 2020, according to Reuters data.
Roche has eight Phase III lung studies under way evaluating Tecentriq alone or in combination with other treatments in patients with early and advanced stages of lung cancer.
In the study, the Basel-based company said Tecentriq showed “significant improvement” in survival in the lung cancer patients, regardless of whether their tumours produced high levels of a protein, called PD-L1, that may help the disease evade immune system detection.
Roche plans to present more detailed data at a conference later this year.
($1 = 0.9863 Swiss francs)
Reporting by Brenna Hughes Neghaiwi and John Miller; Editing by Sherry Jacob-Phillips and Adrian Croft