Roche Holding AG (ROG.EB) said Monday that the U.S. Food and Drug Administration has granted its drug Tecentriq priority review for the first-line treatment of a type of lung cancer.
Priority reviews are FDA designations given to medicines that can provide significant improvements in the treatment, prevention or diagnosis of a disease. The regulator is to take action on the application within six months, instead of the standard ten.
Tecentriq is currently FDA approved for the treatment of patients with metastatic non-squamous non-small cell lung cancer, or NSCLC, who have disease progression following chemotherapy. It is also approved in the EU and more than 60 countries.
Roche said the FDA review would be for the use of Tecentriq in combination with Avastin and chemotherapy after phase 3 trial results showed potential to provide significant survival benefit in the initial treatment of NSCLC.
The Swiss drug manufacturer currently has eight phase 3 lung-cancer studies underway to evaluate Tecentriq.
First-quarter sales of Tecentriq amounted to 139 million Swiss francs ($139 million), Roche said last month. A decision from the FDA is expected by September 5, 2018.
