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# FDA Approves Takeda NDA for Lung Cancer Therapy
- URL: https://www.fdaweb.com/fda-approves-takeda-nda-for-lung-cancer-therapy/
- Published: 2017-05-01T12:00:00.000Z
- Updated: 2026-09-14T22:21:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138589

FDA has approved a Takeda Pharmaceutical Co. NDA for Alunbrig (brigatinib) for treating patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib. The accelerated approval was based on tumor response rate and duration of response shown in a trial called ALTA trial. It showed that brigatinib was highly effective post-crizotinib with the majority of patients who received 180 mg once daily with a seven-day lead in at 90 mg once daily achieving an overall response and a median duration of response greater than one year, according to the company. “Importantly, the extent of activity among those with brain metastases was also notable,” it adds.