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