Takeda's ALK Inhibitor Alunbrig Receives FDA Priority Review for First-Line Treatment of ALK-Positive Metastatic Non-Small Cell Lung Cancer

On the 25th, Takeda announced that the U.S. FDA has accepted the company’s supplemental new drug application (sNDA) for Alunbrig (brigatinib) and granted it priority review status. This application seeks to expand the indication for Alunbrig as a first-line therapy for the treatment of ALK-positive non-small cell lung cancer (NSCLC). Alunbrig is a next-generation tyrosine kinase inhibitor (TKI) developed by Takeda, designed to selectively inhibit abnormal ALK activity caused by ALK gene alterations.

Approximately 1.8 million new cases of lung cancer are diagnosed worldwide each year, with non-small cell lung cancer (NSCLC) being the most common type. Among patients with NSCLC, 3–5% harbor ALK gene rearrangements, which serve as the primary drivers of cancer progression; ALK inhibitors are particularly effective in this patient population.

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 FDA for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression following crizotinib therapy.

This sNDA is based on the results of the Phase 3 clinical trial ALTA-1L. In this open-label, randomized, multicenter Phase 3 clinical trial, 275 patients with ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC) received treatment with Alunbrig or crizotinib. These patients had not previously received treatment with ALK inhibitors. The trial results demonstrated that, according to investigator assessment, the progression-free survival (PFS) for patients in the Alunbrig group was 29.4 months, compared to 9.2 months in the active control group. For patients with brain metastases, the PFS was 24 months in the Alunbrig group versus 5.6 months in the active control group. Alunbrig also significantly improved patients' quality of life.

“ALK-positive NSCLC is a rare and serious form of lung cancer that is complex to treat. Although progress has been made, there remains an unmet need, with approximately 40,000 patients worldwide diagnosed with this disease each year,” said Dr. Christopher Arendt, Head of the Oncology Therapeutic Area at Takeda. “This represents an important step in expanding treatment options for patients in the United States with ALK-positive metastatic non-small cell lung cancer (NSCLC), and we look forward to continuing our collaboration with regulatory authorities worldwide to bring Alunbrig to newly diagnosed patients with ALK-positive NSCLC.”

References:

[1] Takeda Announces U.S. FDA Grants Priority Review for Supplemental New Drug Application for ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ Metastatic Non-Small Cell Lung Cancer. Retrieved February 24, 2020, fromhttps://www.takeda.com/newsroom/newsreleases/2019/takeda-announces-u.s.-fda-acceptance-of-supplemental-new-drug-application-for-alunbrig-brigatinib-as-a-first-line-treatment-for-alk-metastatic-non-small-cell-lung-cancer/

Flash Update | Takeda’s ALK Inhibitor Receives FDA Priority Review for First-Line Treatment of Patients with Specific Non-Small Cell Lung Cancer

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