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FDA grants priority review to brigatinib for ALK–positive NSCLC
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The FDA granted priority review designation to brigatinib for the treatment of metastatic anaplastic lymphoma kinase–positive non–small cell lung cancer, according to the drug’s manufacturer.
The FDA set an action date for the agent’s application of April 29, 2017, under the Prescription Drug User Fee Act.
“The FDA acceptance of our application is an important milestone in our ongoing efforts to discover, develop and deliver highly innovative treatments for patients with rare cancers,” Paris Panayiotopoulos, president and CEO of Ariad, said in a press release.
The submission included results from the phase 1/phase 2 and pivotal phase 2 ALTA trials — designed to evaluate brigatinib (AP26113, Ariad) in patients with ALK–positive NSCLC who have progressed on crizotinib (Xalkori, Pfizer).
“We are pleased that our significant research and development investments in brigatinib and our work with the FDA are bringing us closer to potentially offering a treatment option for patients with ALK–positive NSCLC who are refractory to crizotinib,” Panayiotopoulos added. “We look forward to continuing to work closely with the FDA during the brigatinib new drug application review and remain committed to developing critical therapies for unserved and underserved small patient populations suffering from rare cancers.”
The agent’s manufacturer intends to submit a marketing authorization application to the European Medicines Agency in early 2017, the release said.