As per the supplemental New Drug Application (sNDA), the Japanese pharma company is seeking approval of ALUNBRIG for the first-line treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC, as detected by an FDA-approved test.
Designed to target and prevent ALK genetic alterations, the tyrosine kinase inhibitor (TKI) already has approval across more than 40 countries, including the US and the European Union. The approval is for the treatment of ALK+ metastatic NSCLC who have taken crizotinib, but their disease has worsened or they cannot tolerate taking the anti-cancer drug.
Takeda Pharmaceutical oncology therapeutic area unit head Christopher Arendt said: “ALK+ 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.
“This is an important first step in expanding treatment options for people with ALK+ metastatic NSCLC in the U.S., and we look forward to continuing to work with regulatory authorities around the world to bring ALUNBRIG to newly diagnosed patients.”
ALUNBRIG’s sNDA as a first-line treatment is supported by the data of a phase 3 trial called ALTA-1L.
The late-stage trial is assessing the safety and efficacy of the lung cancer drug in patients with ALK+ locally advanced or metastatic NSCLC who were not given prior treatment with an ALK inhibitor compared to that of crizotinib in the same patient population.
The ALTA-1L clinical trial met its primary endpoint with ALUNBRIG showing superiority in blinded independent review committee (BIRC)-assessed progression-free survival (PFS), in comparison to crizotinib.
ALUNBRIG’s safety profile in the phase 3 trial was in general consistent with the existing US prescribing information, said Takeda Pharmaceutical.