Roche Holding AG said the U.S. Food and Drug Administration has extended the review period for its lung cancer drug Tecentriq.
The Swiss drugmaker is seeking approval for Tecentriq, combined with Avastin and chemotherapy, as an initial treatment for patients with nonsquamous, non-small cell lung cancer, or NSCLC, that has spread to other parts of the body.
The U.S. regulator lengthened the review period by three months to examine additional information that was requested in support of the supplemental biologics license application for Tecentriq, Roche said in a Sept. 6 release.
The FDA previously granted priority review to the therapy, which means the regulator will take action on the application within six months, compared to the usual 10 months under standard review. The FDA will decide on the Tecentriq combination's approval by Dec. 5.
Roche's application for Tecentriq is based on results from a phase 3 study, called IMpower150, which showed that the combination helped NSCLC patients live longer.
Tecentriq is part of a class of immune system-boosting drugs called checkpoint inhibitors, which target immune checkpoints to prevent cancer cells from hiding from the body's immune system.