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news.Ariad Pharmaceuticals has started a new drug application submission in the US for approval of brigatinib in relapsed, anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC).
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The initiation of a ND submission to the US Food and Drug Administration (FDA) is ahead of the company’s earlier unveiled schedule.
The company’s NDA is a rolling submission which will take place in three parts.
The first submission features all nonclinical portions of the NDA and will be followed by submissions of the chemistry, manufacturing and controls and clinical data.
The rolling NDA submission is antcipated to be complete in the third quarter of this year.
Ariad Pharmaceuticals president and CEO Paris Panayiotopoulos said: "If approved, we believe that brigatinib will become an important new medicine for ALK+ NSCLC patients who have become resistant or intolerant to prior crizotinib therapy and will offer additional hope to these patients and their families."
Brigatinib is an investigational, targeted cancer medicine, which is currently being assessed in the global phase 2 ALTA trial that is the basis for its initial regulatory review.
Ariad has also started the phase 3 ALTA 1L trial to evaluate the efficacy of brigatinib in comparison to crizotinib.
In another development, Ariad has completed two distribution agreements for Iclusig (ponatinib) outside of the US.
Pint Pharma International has been hired to commercialize Iclusig in Latin America in Argentina, Brazil, Chile, Colombia and Mexico.
Biologix FZCo will commercialize Iclusig in the Middle East and North Africa, including in Saudi Arabia, the Gulf Coast Countries, Lebanon, and selected other countries in the region.