FDA Approves Takeda’s ALK Inhibitor Alunbrig (Brigatinib) as First-Line Monotherapy for ALK-Positive Metastatic NSCLC
Takeda
Biopharmaceutical Manufacturer
FDA
U.S. Food and Drug Administration
On the 23rd, information on the FDA website indicated that Alunbrig (brigatinib), an ALK inhibitor developed by Takeda, has been approved for an expanded indication as a monotherapy for the first-line treatment of patients with ALK-positive advanced non-small cell lung cancer (NSCLC). These patients must be confirmed as ALK-positive using FDA-approved testing methods.
Alunbrig is a next-generation tyrosine kinase inhibitor (TKI) developed by Takeda, designed to selectively target and inhibit ALK fusion proteins. In April 2017, it received accelerated approval from the U.S. Food and Drug Administration (FDA) for the second-line treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease had progressed on crizotinib. In addition to its use in lung cancer, this novel agent is currently being evaluated in clinical trials for the treatment of patients with neurofibromatosis type 2.
This approval is based on the positive results from the ALTA-1L trial, a randomized, multicenter, Phase 3 clinical study that evaluated the safety and efficacy of Alunbrig compared with crizotinib in patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who had not previously received an ALK inhibitor.
Trial results demonstrated that Alunbrig was significantly superior to the active control group, showing notable antitumor activity in the subgroup of patients with brain metastases. According to the assessment by the Blinded Independent Review Committee (BIRC), after more than two years of follow-up, Alunbrig reduced the risk of intracranial disease progression or death by 69% in patients with brain metastases. Furthermore, Alunbrig exhibited consistent overall efficacy in the intent-to-treat population; per BIRC assessment, the median progression-free survival (PFS) for patients in the Alunbrig arm was more than twice that of the active control arm, at 24 months versus 11 months, respectively.
We look forward to this innovative therapy benefiting more patients.
References:[1] Alunbrig label. Retrieved May 22, 2020, from https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208772s008lbl.pdf
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