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Takeda's Alunbrig sNDA for ALK-Positive Non-Small Cell Lung Cancer Accepted by FDA

NEW YORK – Takeda Pharmaceuticals said on Monday that its supplemental new drug application to expand the use of brigatinib (Alunbrig) as a first-line treatment for ALK-positive non-small cell lung cancer patients was accepted by the US Food and Drug Administration and granted priority review.

Approximately 3 to 5 percent of NSCLC patients have a rearrangement in the anaplastic lymphoma kinase (ALK). In that subset, the chromosomal alteration was found to be a key driver of disease.

Brigatinib was first granted accelerated approval by the FDA in 2017 for ALK-mutated NSCLC patients whose disease worsened on or failed to respond to crizotinib (Pfizer's Xalkori). Additionally, the second-generation ALK inhibitor received orphan drug designation for the treatment of ALK-positive, ROS1-positive, and EGFR-positive NSCLC.

The sNDA is supported by results from a randomized Phase III ALTA-1L trial, which evaluated brigatinib versus crizotinib in patients with ALK-positive locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor. The data showed that brigatinib had a median progression-free survival of 29.4 months compared to 9.2 months in the crizotinib arm. Overall response rate from brigatinib was 74 percent compared to 62 percent on crizotinib. Median duration of response was not reached at time of data collection for patients on Takeda's drug and was 13.8 months on crizotinib.

Adverse event-related discontinuations occurred in 12.5 percent of patients in the brigatinib arm versus 8.8 percent in the crizotinib arm.

"ALK-positive NSCLC is a rare and serious form of lung cancer that is complex to treat. While progress has been made, unmet needs still exist for the approximately 40,000 patients diagnosed with this disease worldwide each year," Christopher Arendt, Takeda's head of the oncology therapeutic area unit, said in a statement. "This is an important first step in expanding treatment options for people with ALK-positive metastatic NSCLC in the US."