Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) has now left matters in the hands of the FDA concerning the approval of its lung cancer drug candidate brigatinib. The company said that it has completed the rolling submission of the candidate’s new drug application to the regulator.
The drug is an ALK inhibitor targeting metastatic ALK-positive (ALK+) patients with non-small cell lung cancer (NSCLC). The drug is designed to treat NSCLC in patients who have failed treatment with Pfizer Inc. (PFE)’s Xalkori. However, Ariad Pharmaceuticals is also in the process of testing the safety and efficacy of brigatinib in patients with metastatic ALK+ NSCLC who have not received prior treatment of an ALK inhibitor. It is comparing brigatinib with Xalkori in the new patients.
Ariad Pharmaceuticals agreed with the FDA that it will be submitting NDA for brigatinib in patients who have failed prior treatment with an ALK inhibitor in an installment basis, which is what they call rolling NDA submission. In that model, a drug company only forwards to the FDA sections of the application that have been completed instead of waiting until the whole application is completed and ready for submission.
Rolling submission has the benefit of accelerating the approval process of a new drug and that is exactly what Ariad Pharmaceuticals is seeking for brigatinib. The company has requested the FDA to allow a priority review of the drug’s application, which could cut the review time by several months from the standard 12 months.
Positive clinical outcome
Ariad Pharmaceuticals is facing the FDA with confidence that brigatinib will be approved given strong clinical data backing its application. The data that Ariad Pharmaceuticals submitted to the FDA in relation to brigatinib include those from Phase 1/2 and pivotal Phase 2 studies. Data showed that 54% of the patients who received brigatinib treatment met the primary endpoint of the trials.
Other than the FDA, Ariad Pharmaceuticals has plans to seek marketing approval of brigatinib from the European Medicines Agency (EMA) begin early next year.
Ariad Pharmaceuticals is hoping to expand the label of its drug by including metastatic ALK+ NSCLC patients who have not been treated with an ALK inhibitor before. The company has already kicked off a Phase 3 study on that front and success there should widen the addressable market of the drug.