The Food and Drug Administration has granted Priority Review for the supplemental New Drug Application (sNDA) for brigatinib (Takeda) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC).

The sNDA was based on data from the multicenter, open-label, phase 3 ALTA-1L trial that compared the efficacy and safety of brigatinib with crizotinib in ALK+ locally advanced or metastatic NSCLC patients who have not previously been treated with an ALK inhibitor (N=275). Patients were randomized 1:1 to receive brigatinib 90mg once daily for 7 days followed by 180mg once daily or crizotinib 250mg twice daily. The primary end point was progression-free survival (PFS) as assessed by a blinded independent review committee (BIRC). Secondary end points included objective response rate and intracranial response.

Findings from the study showed brigatinib met the primary end point of BIRC-assessed PFS demonstrating superiority to crizotinib (estimated 12-month PFS, 67% [95% CI, 56-75] vs 43% [95% CI, 32-53]; hazard ratio for disease progression or death, 0.49 [95% CI, 0.33-0.74]; P <.001). Additionally, patients treated with brigatinib demonstrated a greater objective response rate (71% [95% CI, 62-78] vs 60% [95% CI, 51-68]) and intracranial response (78% (95% CI, 52-94] vs 29% [95% CI, 11-52]) compared with crizotinib. The safety profile of brigatinib was consistent with that seen in previous studies.

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A Prescription Drug User Fee Act (PDUFA) target action date has been set for June 23, 2020 for the application.

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Brigatinib is marketed under the brand name Alunbrig and is indicated for the treatment of patients with ALK+ metastatic NSCLC who have progressed on or are intolerant to crizotinib.

This article originally appeared on MPR