FDA approves Takeda’s Alunbrig (brigatinib) as a new first-line treatment option for ALK

CAMBRIDGE, Mass. and OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved brigatinib for the treatment of adult patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer confirmed by an FDA-approved test.

This approval expands the existing indications of brigatinib to the first-line treatment area. Brigatinib is a potent and selective next-generation tyrosine kinase inhibitor specifically designed to target ALK molecular changes.

Corporate Leadership Perspective

Teresa, President of Takeda Global Oncology Division Bitetti said: "We are deeply proud of the positive results demonstrated by brigatinib in patients with previously treated ALK-positive non-small cell lung cancer, especially those with brain metastases. Through a solid clinical development program and continued research in the treatment of non-small cell lung cancer, we are committed to providing solutions for lung cancer patients who need new options. This approval is an important development for Takeda's lung cancer product portfolio."

Clinical Expert Comments

Dr. Ross Camidge, director of lung cancer research at the University of Colorado Cancer Center, noted: "ALTA The 1L trial results make brigatinib one of the very few first-line treatment options for ALK-positive lung cancer proven to be superior to crizotinib. Compared with crizotinib, brigatinib showed superior efficacy, particularly in patients with baseline brain metastases, and was less burdensome as a once-daily tablet, which is critical for patients who may need years to control their disease. ”

Key clinical trial data

After more than two years of follow-up, the ALTA 1L trial showed that brigatinib has significant advantages over crizotinib:

Progression-free survival

Brigatinib doubled the risk of disease progression or death, and the median progression-free survival as assessed by a blinded independent review committee was 24 months, compared with 11 months in the crizotinib group.

Overall response rate

As assessed by BIRC, the confirmed overall response rate was 74% in the brigatinib group and 62% in the crizotinib group.

Intracranial efficacy

Among patients with measurable brain metastases at baseline, the confirmed intracranial objective response rate was 78% in the brigatinib group and only 26% in the crizotinib group.

Voice of Patient Organizations

Andrea Stern Ferris, President and CEO of the LUNGevity Foundation, said: "For newly diagnosed patients, especially those whose disease has spread to the brain, this new option brings exciting news to the ALK-positive non-small cell lung cancer community and marks significant progress in lung cancer treatment over the past decade."

ALTA 1L trial details

This global Phase III clinical trial enrolled 275 patients with ALK-positive advanced non-small cell lung cancer who had not received prior ALK inhibitor treatment. Patients were randomized to receive either brigatinib or crizotinib. The primary efficacy endpoint is progression-free survival assessed by BIRC, and secondary endpoints include objective response rate and intracranial objective response rate.

Safety Features

Important warnings and precautions for brigatinib include interstitial lung disease/pneumonitis, hypertension, bradycardia, visual impairment, elevated creatine phosphokinase, elevated pancreatic enzymes, hyperglycemia, and embryo-fetal toxicity. In the ALTA 1L trial, BrigatinibThe incidence rate of serious adverse reactions in the group was 33%. The most common serious adverse reactions included pneumonia, fever and dyspnea.

Basic drug information

Brigatinib has been approved in more than 40 countries including the United States, Canada and the European Union for patients with ALK-positive metastatic non-small cell lung cancer who have disease progression or are intolerant to crizotinib. The drug has received FDA breakthrough therapy designation and orphan drug designation.

Disease background information

Non-small cell lung cancer is the most common type of lung cancer, accounting for approximately 85% of newly diagnosed lung cancer cases worldwide each year. ALK chromosome rearrangement is a key driving factor in some patients with non-small cell lung cancer. About 3-5% of patients with metastatic non-small cell lung cancer have ALK gene rearrangement.

Takeda’s R&D Commitment

Takeda is committed to improving the lives of cancer patients through scientific innovation, focusing on the four major treatment areas of oncology, rare diseases, neuroscience and gastroenterology, and investing in plasma-derived therapies and vaccine research and development.

This article contains forward-looking statements that involve known and unknown risks and uncertainties, and actual results may differ materially from expectations. Takeda has no obligation to update these statements except as required by law.