31
Aug

Ariad finishes rolling NDA for lung cancer; wants sped-up review

Ariad Pharmaceuticals ($ARIA) has finished sending its latest data for brigatinib to the FDA and is now looking to the U.S. regulator for a speedy review.

The Cambridge, physician MA-based company is seeking a license for brigatinib, pill its investigational anaplastic lymphoma kinase (ALK) inhibitor, to be used when patients cannot take or are resistant to Pfizer’s ($PFE) marketed ALK non-small cell lung cancer drug Xalkori (crizotinib).

Ariad said in a statement that it is now seeking accelerated approval for brigatinib from the FDA after asking for its coveted priority review, which means it could be on the market around 3 to 4 months earlier than with a normal review. The U.S. regulator has already given the med its “Breakthrough” tag and allowed the rolling status.

“Many patients with ALK-positive non-small cell lung cancer eventually develop disease progression,” said Dr. Corey Langer, director of thoracic oncology in the Abramson Cancer Center of the University of Pennsylvania and a professor of hematology-oncology in Penn’s Perelman School of Medicine.

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