The FDA granted priority review to a supplemental new drug application (sNDA) for brigatinib (Alunbrig) to treat anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), according to a Takeda Pharmaceutical Company news release.
The drug was designed to target ALKgenetic alterations but has the potential to expand its indication in ALK-positive NSCLC. The agency set a Prescription Drug User Fee Act (PDUFA) target date for June 23, 2020.
“ALK(-positive) NSCLC is a rare and serious form of lung cancer that is complex to treat,” said Christopher Arendt, head of Takeda’s oncology therapeutic area unit, in a press release. “While progress has been made, unmet needs still exist for the approximately 40,000 patients diagnosed with this disease worldwide each year.”
The approval is in response to the phase III ALTA-1L trial results, designed to examine the safety and efficacy of brigatinib in patients with ALK-positive locally advanced or metastatic NSCLC who had not received prior treatment with an ALK inhibitor. The trial met its primary endpoint of progression-free survival, as compared to crizotinib (Xalkori).
The ongoing, randomized, multicenter trial enrolled 275 patients (median age, 58 years) to receive either 180 mg brigatinib with a 7-day lead-in of 90 mg daily, or 250 mg crizotinib twice daily.
“This is an important first step in expanding treatment options for people with ALK(-positive) 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,” said Arendt.
NSCLC accounts for approximately 85% of new lung cancer cases diagnosed annually, according to the World Health Organization. As it pertains to ALK, approximately 3%-5% of NSCLC cases have this rare rearrangement in the ALKgene.
Brigatinib has previously received accelerated approval from the FDA for patients of ALK-positive metastatic NSCLC. Even more, brigatinib received breakthrough therapy designation and orphan drug designation from the FDA for the treatment of this patient population.
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 [news release]. Cambridge, Massachusetts and Osaka, Japan. Published February 24, 2020. https://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/. Accessed February 24, 2020.